End-to-end pharmaceutical CDMO services. From formulation development to commercial supply. WHO-GMP and EU-GMP certified facilities.
Request a ProposalFrom API to finished dosage form. IR, SR, MR, EC tablets. Capsules, liquids, injectables, ointments. Taste-masking and stability optimization.
Method development, validation, forced degradation. ICH stability studies. Certificate of Analysis for every batch.
CTD/eCTD dossier preparation. CDSCO, ANDA (US), EU, WHO PQ, Africa zone filings. DMF and ASMF support.
Lab → pilot → commercial scale-up. Process validation (3 consecutive batches). Equipment qualification (IQ/OQ/PQ).
Dedicated and shared manufacturing lines. Batch sizes from 50,000 to 5 million units. Flexible MOQs for market entry.
Blister, strip, bottle, sachet, vial, ampoule packaging. Customer-specific labelling. Serialization for regulated markets.
Share your requirements. We assess feasibility, timeline, and provide a commercial proposal within 7 working days.
NDA and development agreement signed. Project plan with milestones, timelines, and deliverables.
R&D develops the formulation. Analytical methods developed and validated. Prototype samples for your review.
ICH stability studies initiated. Bioequivalence study coordination if required. Regulatory dossier preparation.
Pilot batches → exhibit batches → process validation. All documentation per GMP requirements.
Ongoing commercial manufacturing with agreed quality standards, lead times, and pricing. Annual product quality reviews.
Share your requirements and we'll respond with a feasibility assessment and commercial proposal within 7 working days.
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