Molkem Labs is an India-based drug development services partner. We take your molecule (or a generic target) and develop it into a robust, regulatory-compliant product through formulation development, analytical and microbiological testing, stability studies, and a regulatory-ready dossier — with comprehensive support to transfer technology and launch your finished formulations through our vetted global network.
Most development programmes don't fail on the science. They fail on the calendar. A filing window, a first-to-file slot, a patent expiry, an investor milestone: the date is set by someone else, and your own R&D bench is already booked on the last project.
That's when it makes sense to bring in a development partner. Molkem Labs plugs an experienced formulation, analytical and regulatory team into your programme on a project basis. You get to a submission-ready dossier faster, without spending the years and capital it takes to build the same capability in-house.
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Take one service, take a few, or hand us the whole programme from concept 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, US FDA, EU, Brazil and ROW markets, built for right-first-time filing.
Explore Information → 07Enabling a seamless transition from development to commercial manufacturing through robust technology transfer and GMP-compliant exhibit batch production for process validation and regulatory submissions.
Explore Information → 08GMP manufacturing of the finished product, run through our vetted global CMO partner network, so there's no owned plant and no capital lock-in for you.
Explore Information →From straightforward oral solids to the tricky, poorly-soluble molecules that need comprehensive development and formulation strategy.
Tablets and capsules, from immediate- to modified- and extended-release.
Solutions for sterile delivery.
Solutions, suspensions and syrups.
Creams, gels and ointments.
Value-added generics and export products developed and filed without stretching your in-house R&D.
Own-label supplement and functional-product formulation with stability and regulatory support.
For overseas clients seeking cost-efficient, regulated quality-standard development services.
Handing your molecule to an outside lab takes trust. So we build the engagement around the two things sponsors worry about most: keeping your IP yours, and making sure the work stands up to an audit.
Every conversation starts under NDA. Your molecule, your data and your know-how stay yours, and we keep data segregated across the whole programme, including the manufacturing network.
An FDA-registered R&D facility that works to ICH guidelines, with 21 CFR alignment and the documentation rigour a CDSCO, US FDA, EU, Brazil or ROW review expects.
A Quality Management System (QMS) standardises workflows to ensure consistent product safety and strict compliance with global regulations. By integrating validated methods and audit-ready data into daily routines, it builds clear, undeniable proof of operational accuracy — stopping critical errors early and preventing costly regulatory delays and product refiling loops.
Drug development services are the outsourced science and regulatory work that turns a known molecule into a finished, approvable medicine. That means preformulation, formulation development, analytical and microbiological testing, stability studies, the regulatory dossier, tech transfer and scale-up. Molkem Labs runs all of it as one drug development service, from concept to market, and coordinates GMP manufacturing through a global partner network.
No. Molkem Labs isn't a drug discovery service provider; we're development-focused, so we don't run drug discovery services like target identification, medicinal chemistry or hit-to-lead. Where we come in is drug discovery support at the next stage: once a molecule exists, we take it through formulation, analytical, stability, regulatory and tech transfer. If you need drug discovery and development services end to end, we handle the development half and coordinate the rest.
Yes, up to a point. We can advise on developability early, meaning how easily a molecule can be formulated and what analytical and stability work it will need, even while it's still with an early drug discovery services team. The formal development work starts once you have a defined candidate to progress.
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, EU, Brazil and ROW markets, following ICH guidelines. The target market is agreed at the feasibility stage because it shapes the studies, documentation and batches required.
Molkem Labs is. The asset-light model means we own the science and coordinate GMP manufacturing through vetted partners, but you still deal with one accountable team from feasibility to commercial batch. It's not a chain of vendors passing your project between them.
It depends on the molecule, the dosage form and the target market. A single analytical method might take weeks; a full concept-to-market programme takes a good deal longer. Your free consultation ends with a realistic timeline mapped to your filing or launch date.
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