Molkem Labs leads analytical methodology development, validation, stability, impurity, and microbiological programmes for drug substances and drug products. Our teams generate controlled analytical procedures, specifications, reports, and regulatory data packages aligned with the product's development stage and target market. Analytical activities are integrated with pharmaceutical formulation development, drug development services, regulatory strategy, and method transfer to help sponsors progress from development decisions to submission and commercial readiness.
Reliable analytical methods are required throughout pharmaceutical development. Delayed method development can affect formulation decisions, stability studies, impurity investigations, exhibit-batch testing, regulatory documentation, and the transfer of methods to a commercial manufacturing site.
Molkem Labs provides project-based analytical R&D support that can supplement internal capacity, address specialised testing requirements, and align analytical activities with the product's development stage and target market. Early scope definition helps establish realistic methods, documentation requirements, and timelines before downstream milestones are affected. Where analytical activities support commercial-scale manufacturing, Molkem transfers methods to the receiving laboratory; commercial manufacturing remains the responsibility of the applicable qualified Contract Manufacturing Organisation (CMO).
Discuss your Analytical Timeline
Molkem Labs supports individual analytical requirements and integrated programmes covering formulation development, stability, regulatory submission, and technology transfer.
We develop and optimise analytical methods for assay, related substances, dissolution, residual solvents, and other product-specific test parameters.
Explore Information → 02We validate or verify analytical procedures according to their intended use, applicable pharmacopoeial requirements, and International Council for Harmonisation (ICH)-aligned performance characteristics.
Explore Information → 03We perform chromatographic testing using high-performance liquid chromatography (HPLC), ultra-performance liquid chromatography (UPLC), gas chromatography (GC), and liquid chromatography-mass spectrometry (LC-MS) to assess identity, assay, purity, impurities, degradation products, and residual solvents.
Explore Information → 04We conduct accelerated, long-term, stress, photostability, in-use, and freeze-thaw studies aligned with product requirements and applicable ICH guidance.
Explore Information → 05We perform microbial-limits, bioburden, endotoxin, antimicrobial-effectiveness, and disinfectant-efficiency testing, with microbiological method development where applicable.
Explore Information → 06We develop methods and perform analysis for genotoxic, nitrosamine, enantiomeric, elemental, process-related, and degradation impurities, where applicable.
Explore Information → 07We test active pharmaceutical ingredients, excipients, raw materials, intermediates, in-process samples, and finished pharmaceutical products against applicable specifications.
Explore Information → 08We prepare protocols, method-development and validation reports, stability documentation, specifications, testing procedures, and analytical method-transfer packages to support regulatory review and receiving-laboratory implementation.
Explore Information →Our analytical work supports materials and samples across pharmaceutical development, from early characterisation and formulation studies to stability, exhibit batches, release testing, and method transfer.
We assess active pharmaceutical ingredients, key starting materials, intermediates, reference standards, and degradation products.
We evaluate excipients and other input materials against applicable specifications and pharmacopoeial requirements.
We assess finished formulations and in-process samples for identity, assay, impurities, dissolution, and product-specific attributes.
We analyse formulation trials, stability samples, cleaning residues, packaging-study samples, and materials generated during scale-up or transfer.
Every programme follows a structured analytical pathway, with the scope and level of validation adapted to the method's intended use, product stage, and target regulatory market.
Instrument selection is based on the analytical objective, material, method requirements, and applicable regulatory expectations. Molkem's listed analytical and microbiological capabilities include the following techniques and systems.
Our laboratory uses HPLC, UPLC, GC, and LC-MS techniques for separation, quantification, and impurity assessment.
Supporting systems include dissolution apparatus, controlled stability and photostability chambers, autoclaves, incubators, air-sampling equipment, colony counters, and microbiological laboratory systems.
Analytical decisions influence product development, specifications, stability conclusions, submissions, and commercial testing. Molkem's project controls are designed to protect confidential information and maintain reliable, traceable analytical records.
Projects commence under a signed Non-Disclosure Agreement (NDA). The customer retains ownership of its molecule, formulation, data, and proprietary information. Ownership and permitted use of newly developed analytical methods and project-specific deliverables are documented in the engagement, while controlled access and secure data-handling procedures are designed to protect confidential information.
Analytical activities are supported by an FEI- and EMA SPOR-registered Analytical Development Laboratory (ADL) facility, 21 CFR-compliant systems, and development practices aligned with ICH quality guidelines. Documentation is prepared to support applicable submissions and technical review by the Central Drugs Standard Control Organisation (CDSCO) in India, the United States Food and Drug Administration (US FDA), European Medicines Agency (EMA), Brazilian Health Regulatory Agency (ANVISA), Health Canada, Therapeutic Goods Administration (TGA), National Medical Products Administration (NMPA), and Rest of World (ROW) authorities. These controls help support regulatory review across regulated and emerging markets.
Our Quality Management System (QMS) standardises analytical workflows, supports data integrity, and maintains traceability across development and testing activities. Controlled procedures, reviewed records, validated methods, and risk-based quality practices help reduce analytical uncertainty and support audit readiness.
Analytical research and development creates and applies the test methods used to assess the identity, strength, quality, purity, potency, stability, and impurity profile of drug substances and drug products. It supports formulation development, specifications, stability programmes, regulatory submissions, method transfer, and commercial testing.
Analytical R&D develop, optimise, validate, verify, and transfer methods for defined purpose during product development. Routine quality control applies approved procedures to raw materials, in-process samples, finished products, stability samples, or release testing. The two functions are connected, but their objectives and development responsibilities differ.
Molkem provides method development, validation and verification, chromatographic analysis, dissolution, stability studies, microbiological analysis, impurity testing, raw-material and finished-product testing, cleaning-method validation, documentation, and analytical method-transfer support.
The required validation level depends on the analytical procedure's intended use, development phase, product type, applicable pharmacopoeial status, and regulatory pathway. Molkem defines the relevant performance characteristics and documentation scope during the analytical assessment.
Molkem's listed scope includes analysis and method-development support for genotoxic, nitrosamine, enantiomeric, elemental, process-related, and degradation impurities, where applicable. The recommended technique and study design depend on the impurity, matrix, reporting requirement, and target market.
Molkem prepares analytical documentation to support applicable submissions and technical review for CDSCO (India), US FDA, EMA, ANVISA, Health Canada, TGA, NMPA, and Rest of World (ROW) markets. The precise analytical and documentation requirements are defined according to the product, development stage, submission pathway, and target authority.
Projects commence under a signed Non-Disclosure Agreement (NDA). The customer retains ownership of its molecule, formulation, data, and proprietary information. Access controls, secure data handling, controlled records, and engagement-specific ownership terms are used to protect confidential information and define the permitted use of newly developed methods and deliverables.
Cost depends on the molecule or product, sample matrix, analytical objective, method status, required techniques, validation scope, number of samples, stability conditions, documentation requirements, and target market. Molkem provides a cost proposal after the initial analytical assessment and definition of the recommended scope of work.
Evaluate the company's relevant technical scope, instruments, method-development experience, validation and transfer capability, quality systems, data-integrity controls, documentation standards, confidentiality measures, regulatory-market understanding, and ability to define a realistic project scope and timeline.
Share the molecule or product concept, development stage, analytical requirement, available methods or data, and target market. A business development executive will provide an initial developability and analytical requirements assessment, recommended scope of work, development timeline, and cost proposal under a signed Non-Disclosure Agreement (NDA), with no obligation to proceed.
Analytical work is usually scoped alongside these Molkem Labs services.
Preformulation, formulation development, stability and CTD/eCTD dossier — turning a molecule into a stable, manufacturable finished product.
Explore Information →End-to-end development from early discovery support through to regulatory submission and commercial readiness.
Explore Information →Our integrated R&D and analytical development centre — the full concept-to-market capability behind every programme.
Explore Information →
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