Bioanalysis Services

Analytical Chemistry &

End-to-end analytical chemistry solutions that combine technical excellence, regulatory expertise, and scientific insight.

Analytical Chemistry and Bioanalysis Services

QIMA Life Sciences provides analytical chemistry and bioanalysis services that combine technical depth, regulatory‑aligned workflows, and scientific insight across development stages. Delivered through specialist laboratories within the QIMA Life Sciences network, our capabilities support formulation development, stability assessment, impurity and degradation control, and exposure‑related analytical studies.

Our focus is on generating reliable, decision‑ready analytical data to support product safety, quality, and regulatory compliance across pharmaceutical, cosmetic, nutraceutical, veterinary, and medical device sectors.

Our Analytical Chemistry Capabilities at a Glance

Markets Served

Pharmaceuticals
Cosmetics
Veterinary Medicine
Medical Cannabis
Medical Devices
Chemicals

Study types and core services

Routine analytical testing & QC
Method development & validation
Stability & shelf‑life studies
Advanced characterisation
Forced degradation studies
Bioanalysis & PK/PD support

Compatibility & thermal studies
Impurity, degradation & chemical risk
Dissolution & release studies
Residual solvents & nitrosamines
Elemental & metallic impurities
Extractables & leachables

Quality & Compliance

GLP‑aligned laboratory operations: REBLAS‑ and ANVISA‑authorised with robust data integrity systems.

Validated analytical systems: Qualified, calibrated instruments.

Global regulatory readiness: Aligned with ICH, USP, EMA, and FDA.

Samples & Matrices

Pharmaceutical & cosmetic formulations in various states.

Biological matrices: Blood & biofluid samples, tissues, and non‑invasive, biopsy or reconstructed skin models.

Natural extracts, active ingredients, and raw materials

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Foundations of our Analytical Chemistry Services

Our analytical chemistry services follow the same principles as QIMA Life Sciences’ integrated research solutions, bringing together specialist analytical laboratories and centres of excellence in a global, comprehensive service model. Our approach is centred on close scientific collaboration, clear communication, and analytical work delivered in context, with clients benefiting from our long‑standing commitments to quality, efficiency and added value.

Specialist depth, network scale

Our services are delivered by specialist laboratories with deep technical expertise in defined areas, from formulation studies to natural‑derived materials. By coordinating this depth within an integrated service model, clients can access the right expertise at the right stage, with data continuity and seamless connection to preclinical and clinical services.

Quality- & decision-driven data

Our analytical studies are conducted within established quality and regulatory frameworks and designed to support development decisions. This ensures methods, data, and reporting are compliant while remaining directly relevant to study objectives, development strategy, risk assessment, and downstream regulatory requirements.

Collaborative project management

Projects are managed through close collaboration with our clients, and within multidisciplinary and highly qualified science teams. This approach brings adaptability to project needs, keen awareness of timelines and priorities, and added value through technical and regulatory consulting and ongoing scientific support.

Analytical Chemistry Studies and Core Services

Our analytical chemistry services cover a broad range of study types and service offerings with different objectives. Each tab below reflects the scope of analytical chemistry solutions delivered across the QIMA Life Sciences network, outlining what each service or study involves, how it is typically applied, and our alignment with relevant regulatory contexts. While ANVISA requirements are most often cited due to the location of our analytical labs, note that our studies fully meet even the strictest international regulations and criteria for analytical methods.

Routine analytical testing & QC

Our analytical testing supports the consistent assessment of materials, intermediates, and finished products throughout development and manufacture. These services are typically applied to confirm identity, content, purity, and consistency against defined specifications, and to support ongoing quality control activities.

This analytical testing is performed within established quality frameworks and adapted to the specific requirements of each product, study, or regulatory context. Results are generated to be reliable, traceable, and fit for purpose.

Quality parameters may include:

Active pharmaceutical content.
Identification.
Humidity.
Degradation products.
Dissolution.
Elemental impurities.

Example service case: characterisation of a reference substance

As a high level example of analytical testing, we characterise substances for use as characterised chemical reference materials, following regulatory precedents like ANVISA RDC 166/2017. Studies are designed to confirm identity, purity, and content, supporting their use in quality control and regulated testing.

Depending on the analyte, characterisation may combine chromatographic, spectroscopic, mass‑based, and thermal techniques, among others. A conclusive characterisation report is issued, aligned with applicable regulations. While RDC 166/2017 is one reference point, our approaches meet or can be adapted to meet other international or project‑specific requirements (e.g. ICH Q2, ICH Q6A).

Method development & validation

Analytical method development and validation supports the generation of reliable, reproducible workflows and data for defined use cases. These services are typically applied when new analytes, formulations, or matrices are introduced, or when existing methods must be adapted to evolving specifications or study objectives.

These projects require a strong understanding of the physicochemical characteristics of the analyte, appropriate sample preparation and extraction from the relevant matrix, and selection of chromatographic and detection approaches suited to the substances under investigation. Our experience across a wide range of study types and analytical techniques, combined with specialist laboratory expertise, positions us well to develop and validate methods that are robust and fit for purpose.

Validation parameters may include:

Specificity.
Linearity.
Accuracy.
Precision.
Detection and quantitation limits.
Robustness.

Example service case: rational stability‑indicating method development

As an example of method development and validation, we develop analytical methods to monitor active content and related impurities during stability studies. In this context, methods are designed to resolve the active substance from degradation products under defined stress conditions. One‑factor‑at‑a‑time and Quality by Design (QbD) principles are often used, including Design of Experiments (DoE), to optimise method development. These approaches are underpinned by the practical expertise of our Science teams, who also deliver technical training and courses in method development, QbD, and DoE.

Stability & shelf‑life studies

Stability and shelf‑life studies investigate how substances and products change over time under defined storage environments. These studies are used to evaluate the impact of formulation, packaging, and environmental exposure on product quality, and to generate data that underpin shelf‑life assignment and storage recommendations.

Studies are designed based on the physicochemical properties of the material, formulation characteristics, and intended conditions of storage and use. Our multi-lab expertise across a wide range of materials and dosage forms enables the generation of stability data that are fully suitable for development decision‑making, refinement and regulatory submission.

Stability parameters may include:

Active content/potency.
Degradation products.
Physical appearance.
Dissolution or release behaviour.
Relevant impurity profiles.
Physicochemical properties (e.g. moisture content, pH).

Example service case: shelf‑life assessment under defined climatic conditions

We regularly design and execute stability studies to establish the shelf life of drug substances or formulated products stored under controlled temperature and humidity conditions. Studies are conducted using stability chambers compliant with ICH climatic zones II and IV, incorporating long‑term, intermediate, and accelerated conditions as appropriate.

Stability studies are designed and evaluated in accordance with recognised frameworks such as RDC 318/19 (or ICH Q1). Stability‑indicating analytical methods are established, validated, and used to analyse samples at predefined intervals, ensuring changes in active content, impurity levels, and other critical quality attributes are reliably detected and interpreted.

Forced degradation studies

Forced degradation studies investigate how substances and products degrade when exposed to defined stress conditions. These studies are used to characterise intrinsic degradation pathways, generate representative degradation products, and demonstrate the specificity and suitability of stability‑indicating analytical methods; they are essential to bringing a drug to market.

Studies are designed by selecting stress conditions and exposure durations in line with applicable regulatory expectations (e.g. RDC 964/2025, ICH Q1A/Q1B), ensuring degradation is induced in a controlled and interpretable manner.

Degradation forcing conditions may include:

Thermal stress.
Hydrolytic conditions.
Oxidative stress.
Photolytic exposure.
Acidic or basic conditions.
Matrix‑ or formulation‑specific stress factors.

How we conduct forced degradation studies

Forced degradation studies are executed according to protocols that align with analytical objective and can be guided by theoretical predictions of likely degradation pathways. Stress conditions and exposure durations are selected to generate meaningful and controlled levels of degradation, typically targeting approximately 5–20%; sufficient to reveal relevant degradation pathways without causing non‑representative breakdown.

Analytical evaluation focuses on the use of stability‑indicating chromatographic methods, with preference to approaches compatible with mass spectrometric detection for degradation product identification. Degradation products may also be identified, isolated, or synthesised for deeper characterisation.

Dissolution & formulation performance

Dissolution and formulation performance studies investigate how formulation composition and processing influence the release of an active substance under defined test conditions. These studies are used when comparing formulation options, assessing the impact of excipients or manufacturing changes, and generating data to inform formulation selection and consistency.

These studies are designed to generate predictive insight into formulation behaviour within relevant physicochemical and physiological niches.

Performance characteristics may include:

Dissolution or release profiles over time.
Rate and extent of release.
Formulation‑dependent variability.
Sensitivity to media composition or test conditions.
Comparative performance between formulations.
Batch consistency.

How we conduct dissolution and formulation performance studies

Dissolution and formulation performance studies are conducted using defined dissolution apparatus (often flow through cells) and media, selected according to formulation type and intended route of administration. Test conditions are designed to reflect physiologically relevant pH ranges (pH 1.2 – 6.8), with sampling time points and test parameters tightly controlled to ensure meaningful performance profiles.

Study design and interpretation follow guidance including ANVISA Technical Note No. 003/2013, RDC No. 31/2010, and Guide No. 14/18 for solubility, alongside relevant ICH frameworks . This approach supports scientifically robust interpretation of formulation performance while remaining appropriate for regulated development contexts.

Compatibility & thermal studies

Compatibility and thermal studies investigate interactions between active substances, excipients, and formulation components under defined conditions. These studies are used to identify physical or chemical incompatibilities, assess solid‑state behaviour, and anticipate risks that may affect formulation stability, performance, or manufacturability.

Studies are designed to evaluate material behaviour under conditions representative of formulation, processing, storage, and use. The compatibility data we generate helps inform formulation design, excipient selection, and risk‑based development decisions.

Compatibility and thermal characteristics may include:

Active-excipient compatibility.
Thermal transitions and phase behaviour.
Hygroscopicity and moisture sensitivity.
Solid‑state interactions.
Stress‑induced physical or chemical changes.
Matrix‑dependent compatibility effects.

Example service case: deep compatibility assessment of a formulation

For in‑depth compatibility studies, we may test interactions between an active substance and various formulation components at maximum and minimum relevant concentrations to represent potential extremes encountered during manufacture, storage, and use.

A combination of complementary techniques is applied, including Differential Scanning Calorimetry (DSC) and Thermogravimetric Analysis (TGA) to assess thermal behaviour and physical transitions, alongside high‑performance liquid chromatography (HPLC) and liquid chromatography–mass spectrometry (LC‑MS) to monitor chemical stability and interaction‑driven changes. Where lipid‑based excipients are involved, iodine value (IV) determination is used to assess susceptibility to oxidative change.

Compatibility with fluids used for reconstitution or dilution may also be evaluated to identify interaction risks at the point of use. Where relevant, initial screening of compatibility with packaging materials can be performed, with detailed extractables and leachables studies addressed separately when required.

Risk, safety & cleaning assessment

Risk and safety assessments address hazards that may affect patient, user, or operator safety across pharmaceutical, cosmetic, veterinary, and medical device products. These studies are used to identify, quantify, and control risks arising from impurities, materials, and manufacturing processes and to meet legislative needs. For medical devices, analytical studies may provide characterisation and risk‑supporting data aligned with ISO 10993 frameworks, while for cosmetics they can ensure the absence of restricted substances and allergens (aligning with RDC 530/21 or Annex III of the EU Cosmetic Regulation (EC) No 1223/2009).

Cleaning studies can be used to verify the effectiveness of defined cleaning procedures in removing residues to acceptable levels.

Our risk, safety, and cleaning services include:

Residual impurities and process‑related substances (e.g. solvents, elemental impurities).
Material and formulation compatibility risks (e.g. extractables and leachables).
Allergenic and prohibited substances.
Chemical and biological safety considerations for medical devices.
Cross‑contamination and carryover potential between products.
Verification of cleaning effectiveness and residue removal.

Example service case: analytical cleaning and safety assessment

We often perform analytical assessments to verify that established cleaning procedures effectively remove residues of given substances from manufacturing equipment. These studies enhance contamination control across various industries and can proactively mitigate chemical and biological risk factors.

Cleaning assessments are developed based on the specific product, process, and equipment involved. We work in partnership with customers to define the analytes, acceptance criteria, cleaning procedures, analytical methods, sampling strategy and validation, and reporting for these studies.

Residual solvents, nitrosamines & elemental impurities

Residual solvents and nitrosamines and elemental impurities may arise from synthesis routes, raw materials, processing conditions, or degradation pathways. Nitrosamines are of particular concern due to their mutagenic potential, commonality, and the very low acceptable intake limits applied across markets.

Control of residual solvents and nitrosamines is addressed through internationally harmonised guidance, including ICH Q3C for residual solvents, ICH M7 for mutagenic impurities, and the ICH Q3A/Q3B/Q3D series covering organic, inorganic, and elemental impurities, alongside region‑specific expectations. These frameworks adopt a staged, risk‑based approach to identification, assessment, and control across development and commercial manufacture.

Our chemical analysis solutions include:

Residual solvent identification and quantification.
Nitrosamine risk assessment, screening, and targeted analysis.
High‑sensitivity detection of nitrosamines and nitrites.
Method development for contaminant analyses.
Synthesis and characterisation of reference standards.
Trace‑level impurity monitoring and control verification.
Routine analytical support for impurity mitigation strategies.

Extractables & leachables

Extractables and leachables studies assess the potential for substances to migrate from packaging materials or manufacturing components into a product over its lifecycle. Extractables are substances released from materials under harsh or aggressive conditions, while leachables are those that migrate into the product under normal conditions of use. Studies are designed to evaluate material-product interactions under high‑risk conditions to identify any substances of concern before they present downstream risk.

Extractables and leachables services may include:

Design and execution of extractables and leachables studies under defined and exaggerated conditions.
Development and validation of analytical methods for detected or predicted contaminants.
Application of high‑sensitivity analytical techniques for screening, identification, and quantification.
Critical analysis reporting.

Further characterisation of pharmaceutical packaging

We also perform conformity assessment and characterisation of primary pharmaceutical packaging to support release for use and compliance with good manufacturing practices. Packaging characterisation is conducted in accordance with RDC No. 17/2020, alongside standards such as Brazilian Pharmacopoeia, and USP <660> (Glass Containers) and <661> (Plastic Packaging Systems and Materials of Construction).

For glass packaging, including type I, II, and III (transparent and amber), attributes such as volumetric capacity, hydrolytic resistance, spectral transmission, and arsenic content may be evaluated. For plastic packaging, characterisation may include ATR‑FTIR identification, differential scanning calorimetry (DSC), X‑ray diffraction (XRD), and assessment of solid residues, buffering capacity, and heavy metals. Typical materials evaluated include caps, bottles, and mono‑ or multilayer films, with additional analyses developed on demand.

Advanced characterisation

Advanced characterisation studies enable deeper analytical insight to understand the composition, structure, or behaviour of substances, formulations, or materials. These studies are typically used to investigate unknown or unexpected components, support deformulation and root‑cause analysis, and resolve analytical questions that cannot be addressed through routine testing alone.

Our specialist experience across complex formulations, natural‑derived materials, and challenging matrices enables the generation of characterisation data that are interpretable and applicable.

Advanced characterisation is commonly applied to:

Pharmaceutical products, including deformulation and identification of unknowns.
Cosmetics and personal care products, including assessment of prohibited or residual substances (e.g. benzene, benzophenone, ethylene glycol, 1,4‑dioxane, acetaldehyde), ester content, lipid compositions.
Nutraceuticals and supplements, including compositional profiling and impurity determination.
Natural‑derived materials and botanicals, including extract profiling, marker identification, and evaluation of batch variability.

Example service case: advanced characterisation of complex and natural‑derived materials

We provide expert services for phytochemistry and pharmacognosy, to determine the composition of complex formulations or natural‑derived materials where standard analytical approaches are insufficient. Studies may involve development of tailored extraction and fractionation strategies to enrich or isolate specific classes of compounds, followed by chromatographic and spectrometric profiling to establish a representative chemical fingerprint.

Analytical strategies are applied to track chemical classes, identify and characterise marker compounds, and support quantitative determination where required. Where appropriate, chemical markers may be isolated and fully characterised to confirm structure, purity, potency, and suitability for use as reference substances. These studies support pharmaceutical, cosmetic, nutraceutical, and herbal medicinal applications.

Bioanalysis & PK/PD support

Our bioanalysis capabilites provide an analytical bridge between physicochemical characterisation and biological evaluation during development. These services are applied where quantitative measurement of compounds in biological matrices is required to support pharmacokinetic assessment, exposure analysis, and interpretation of in vivo study data.

Within QIMA Life Sciences, bioanalytical capabilities are integrated with complementary clinical trial activities in Latin America, enabling analytical chemistry and bioanalysis to align closely with regional clinical development programmes. Our teams are also experienced in the bioanalysis of preclinical and veterinary samples, supporting exposure assessment across a wide range of development contexts.

Bioanalysis and PK/PD activities may include:

Development and application of bioanalytical methods for matrices and modalities.
Quantification of compounds across defined sampling schedules to characterise pharmacokinetic profiles.
Residue depletion studies for veterinary pharmacology in varied matrices (muscle, fat, kidney, liver, milk and more).
Analysis, calculation of PK parameters, and critical reporting.

Example service case: bioanalysis for rodent pharmacokinetic and bioequivalence studies

As an example, we provide bioanalytical services for rodent pharmacokinetic studies (and also have the ability to conduct the in-life phase of these studies), veterinary exposure assessments, and human bioequivalence studies, where reliable quantification across defined sampling schedules is required. Bioanalytical methods are developed and applied to establish validated calibration curves and ensure sensitivity and selectivity across the expected concentration range.

After successful validation, these studies typically entail analysis of dosing solutions to confirm actual versus theoretical concentrations, quantification of compounds in the biological matrices, and calculation of key pharmacokinetic parameters from the data.

Analytical Instrumentation and Technology

Our analytical chemistry services are delivered using a comprehensive and tightly controlled technology stack operated within GLP‑compliant laboratory environments, including REBLAS‑accredited facilities. Instrumentation is routinely qualified, calibrated, and performance‑verified, supported by full proficiency testing and certification (e.g. Controllab) to ensure analytical reliability.

These systems operate under robust data integrity, control, and traceability frameworks, meeting expectations for regulated use across ANVISA, FDA, EMA, ICH, and USP contexts. This ensures analytical data generated across the QIMA Life Sciences network are consistent, defensible, and suitable for development, submission, and audit.

Chromatographic separation equipment

40+ liquid chromatography (LC) systems, primarily ultra‑high‑performance liquid chromatography (UHPLC).
LC systems configured with mass spectrometry (MS), diode array detection (DAD), fluorescence detection (FL), and refractive index detection (RID).
Gas chromatography with flame ionisation detection (GC‑FID) and gas chromatography–mass spectrometry (GC‑MS) systems dedicated to residual solvents, extractables and leachables, and medical device characterisation.
High‑throughput and high‑resolution configurations supporting quality control, stability, dissolution, and impurity studies.

High performance liquid chromatography HPLC

Mass spectrometry and trace detection

UHPLC‑coupled triple quadrupole mass spectrometry (QqQ‑MS) for high‑accuracy quantification.
22 liquid chromatography–tandem mass spectrometry (LC‑MS/MS) Q‑Trap systems supporting routine and trace‑level analysis.
3 UHPLC high‑resolution mass spectrometry (HRMS) Orbitrap‑class systems for accurate‑mass identification.
3 liquid chromatography–mass spectrometry quadrupole time‑of‑flight (LC‑MS Q‑TOF) systems for full‑scan and unknown elucidation.
Trace‑level workflows supporting nitrosamines, impurities, extractables and leachables, and bioanalysis.

Spectroscopy and structural characterisation

Nuclear magnetic resonance (NMR) spectroscopy.
Fourier‑transform infrared (FTIR) spectroscopy, including attenuated total reflectance (ATR‑FTIR).
Ultraviolet–visible (UV‑Vis) spectrophotometry.
X‑ray diffraction (XRD).
Atomic absorption spectroscopy (AAS).
Structural confirmation, solid‑state analysis, and deformulation support.

Thermal and physicochemical analysis

Differential scanning calorimetry (DSC).
Thermogravimetric analysis (TGA).
Melting behaviour and phase transition analysis.
Moisture determination (e.g. Karl Fischer titration).
Lipid stability metrics including iodine value (IV).
Support for compatibility, stability, excipient, and packaging studies.

Elemental, ion, and specialised analysis

Inductively coupled plasma–mass spectrometry (ICP‑MS) with microwave digestion for elemental impurities.
Inductively coupled plasma–optical emission spectrometry (ICP‑OES) for multi‑element analysis.
Ion chromatography (IC) systems for anion and cation analysis.

Frequently Asked Questions (FAQS)

When should analytical chemistry be engaged during development?

Analytical chemistry is most effective when engaged early, although the timing may vary depending on budget, pipeline maturity, and development strategy. Early involvement helps establish a robust chemical foundation, for example understanding solubility, formulation behaviour, and composition. This in turn makes downstream medicinal and biological investigations more interpretable. Continued engagement across development supports consistency, comparability, and regulatory readiness as products progress toward clinical and commercial stages.

Can your analytical methods support regulatory submissions in different regions?

Yes. Analytical studies are designed to be adaptable to different regional regulatory expectations and submission contexts and are aligned with international standards. Rather than following a single jurisdictional framework, methods and data packages are structured to support use across multiple regulatory environments, and follow the most stringent guidelines possible.

How are your studies adapted to different regulatory requirements and product types?

Analytical studies are designed using internationally recognised frameworks and adapted to the specific regulatory and product context rather than following a single jurisdictional template. For example, in medical device development, analytical chemistry supports chemical characterisation and safety evaluation through studies aligned with ISO 10993‑18, including stress studies, device material characterisation, and calculation of the Analytical Evaluation Threshold (AET). These workflows may involve techniques such as headspace GC‑FID/MS, GC‑FID/MS, UHPLC‑PDA, high‑resolution UHPLC‑MS/MS, and ICP‑MS/OES, supported by compound libraries for tentative identification of extractables.

The same principles—risk‑based study design, regulatory alignment, and analytical justification—are applied across pharmaceuticals, cosmetics, and other regulated products, allowing analytical strategies to be scaled and adapted as programmes move between regions, indications, and development stages.

How do you ensure data integrity and audit readiness across analytical studies?

Analytical work is performed within controlled laboratory environments using qualified and calibrated instrumentation, with defined procedures for data handling, traceability, and review. This ensures that analytical data are reproducible and suitable for audit or regulatory inspection.

How do you support decision‑making when analytical results are ambiguous or unexpected?

When analytical datasets don’t provide clear conclusions, additional investigative and orthogonal approaches are often applied to clarify causes and the underlying chemical reality. This may include advanced characterisation, alternative sample preparation strategies or analytical methods, and targeted stress or compatibility studies. These activities are carried out in close collaboration with client teams to iteratively refine the analytical approach and ensure the resulting data can be acted upon and studies continue to fit the scope of the development programme.

Discuss your Analytical Strategy with our Scientists

Analytical chemistry is an essential part of developing and delivering marketable products, underpinning decisions from formulation refinement and impurity control to stability, safety, and regulatory readiness. QIMA Life Sciences provides an integrated portfolio of analytical chemistry, advanced characterisation, and bioanalytical capabilities as a core component of our global services, supporting pharmaceutical, cosmetic, nutraceutical, veterinary, and medical device development across a wide range of indications and R&D programmes.

Our approach supports routine testing, formulation optimisation, risk and safety assessment, and bioanalysis across preclinical, clinical and post-market contexts. Whether you’re establishing an analytical strategy, refining a formulation, or preparing for regulatory submission, our scientists work closely with your team to generate reliable, defensible data.

Do you have a project requiring analytical expertise?
Let’s discuss it today!

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