Molkem Labs operates a development-focused, asset-light model. We lead and manage the formulation science, analytical methodology, and regulatory dossier development, and coordinate commercial-scale manufacturing through a network of qualified Contract Manufacturing Organisations (CMOs).
Successful pharmaceutical development depends as much on timing as it does on science. Whether you are pursuing a first-to-file strategy, preparing for a global product launch, meeting regulatory timelines, or advancing an investor-backed pipeline, every delay can affect commercial success. Developing internal formulation capabilities demands substantial investment, infrastructure, and specialised expertise, while stalled development programmes can further compromise timelines.
Molkem Labs serves as an integrated pharmaceutical development partner, combining formulation science, analytical development, regulatory expertise, and technology transfer to help accelerate the path from molecule to market.
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Take one service, take a few, or hand us the whole programme from molecule to commercial batch.
Solubility study, excipient compatibility study, forced-degradation study, reverse engineering of reference products, polymorphism screening, particle size determination and powder-flow determination.
Explore Information → 02Design and development of robust formulations for immediate, modified and controlled-release dosage forms, covering NCE, generic and 505(b)(2) product development across dosage forms.
Explore Information → 03Method development and validation/verification for assay, related substances, dissolution and other test parameters, in line with ICH.
Explore Information → 04Microbial limits, bioburden, endotoxin and antimicrobial-effectiveness testing for sterile and non-sterile products.
Explore Information → 05ICH-guided accelerated, long-term and stress studies that fix shelf life, storage conditions and packaging suitability for your submission.
Explore Information → 06CTD/eCTD dossier preparation and regulatory strategy for CDSCO (India), US FDA, EMA, ANVISA, Health Canada, TGA, NMPA, and Rest of World (ROW) markets, designed to support right-first-time filing.
Explore Information → 07A structured transition from development to commercial manufacturing through robust technology transfer and GMP-compliant exhibit batch production for regulatory submissions.
Explore Information → 08Coordination of finished-product GMP manufacturing through our vetted global CMO partner network, with no owned plant or capital lock-in for the customer.
Explore Information →Our formulation development capability spans oral solids to sterile parenteral solutions, covering the dosage forms required for submission in regulated markets.
Tablets and capsules, spanning immediate-release to modified- and extended-release formulations.
Solutions, suspensions, and syrups.
Sterile injectable solutions, including small-volume parenterals.
Creams, gels, and ointments.
At Molkem Labs, every development programme follows a structured, science-driven pathway designed to minimise risk, accelerate timelines, and ensure regulatory readiness for global markets.
Every development programme is supported by robust quality systems, regulatory rigour, and strict confidentiality, ensuring that each molecule progresses securely from concept to commercialisation.
All projects commence under a comprehensive Non-Disclosure Agreement (NDA), with clearly defined ownership of intellectual property. The customer's molecule, data, formulations, and proprietary know-how remain exclusively theirs throughout the development lifecycle.
Secure data-management practices, controlled-access systems, and confidential project workflows are designed to protect sensitive information across development activities and manufacturing-partner networks.
Molkem Labs operates an FEI- and EMA SPOR-registered Analytical Development Laboratory (ADL) facility with 21 CFR-compliant systems and development practices aligned with ICH guidelines. We generate scientific data and documentation that supports regulatory submissions across regulated and emerging markets.
We support product development and regulatory filings for CDSCO (India), US FDA, EMA, ANVISA, Health Canada, TGA, NMPA, and Rest of World (ROW) markets.
Quality is embedded into every stage of the development process, rather than inspected only at the end. Our integrated Quality Management System (QMS) standardises scientific workflows, supports data integrity, and maintains traceability throughout the product-development lifecycle.
Through validated analytical methods, comprehensive documentation, risk-based quality management, and audit-ready processes, we help minimise development risks, support efficient regulatory review, and advance commercial readiness.
A pharmaceutical formulation company turns a known molecule into a stable, manufacturable finished product and the documentation to file it — preformulation, formulation development, analytical and stability studies, scale-up, technology transfer and the regulatory dossier. Molkem Labs runs all of this as one programme, from molecule to market, and coordinates GMP manufacturing through a vetted CMO network.
We are development-focused and asset-light: Molkem Labs leads and manages formulation science, analytical methodology, and dossier development, and coordinates commercial manufacturing through vetted Contract Manufacturing Organisation (CMO) partners rather than an owned plant. This provides scientific accountability and a credible path to commercial supply without implying that Molkem owns the manufacturing facility.
Our pharmaceutical formulation development services span preformulation, formulation development, analytical method development and validation, stability studies, scale-up and exhibit batches, technology transfer and CTD/eCTD dossier preparation. Buyers comparing drug formulation companies or drug formulation services usually need most of this chain, so we scope it as one accountable programme or as individual services.
Oral solids (tablets and capsules, immediate- to extended-release), oral liquids (solutions, suspensions and syrups), sterile parenteral solutions, and semi-solids and topicals (creams, gels and ointments). We're honest about scope up front, so you never find a capability gap mid-project.
Yes — our preformulation and formulation team designs for solubility, bioavailability and stability, and we assess developability early so you know what a difficult (e.g. poorly soluble) molecule will need before the programme commits.
Every engagement starts under a signed NDA. Your molecule, your data and your formulation know-how stay your property, and data is kept segregated across the programme, including the manufacturing partner network. IP ownership is written into the agreement before any material or data changes hands.
We build development data and dossiers for CDSCO (India), US FDA, EMA, ANVISA, Health Canada, TGA, NMPA, and Rest of World (ROW) markets, following ICH guidelines. The target market is agreed at the feasibility stage because it shapes the studies, documentation, and batches required.
It depends on the molecule, the dosage form, the target market and how much of the programme you outsource — there's no flat price list. We provide a written scope, a realistic timeline and a stage-wise cost, so you decide with the number in front of you.
Formulation work is usually scoped alongside these Molkem Labs services.
Method development and validation, stability and impurity studies, microbiological testing and analytical method transfer.
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.
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