WHAT WE DO
Pharmaceutical Development Services — From Formulation to Regulatory Filing
From early formulation decisions to stability, packaging compatibility, and CTD/eCTD-ready documentation.
Deliverables are tailored to your stage and target markets—focused on clarity, traceability, and transfer readiness.
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Formulation Development and Optimization
Prototype formulation design across all dosage forms — tablets, capsules, injectables, and semi-solids. Includes excipient screening, compatibility evaluation, and scale-up strategy with complete development documentation.
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Analytical Method Development and Validation
ICH Q2(R1)-compliant development and full validation of HPLC, UV, dissolution, and assay methods. Method transfer packages and system suitability protocols included.
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Packaging Development and Compatibility Studies
Primary and secondary packaging evaluation including extractables, leachables, and accelerated stress compatibility per ICH Q1B. Container closure integrity documentation provided.
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API/Excipients Vendor Qualification
Supplier audit frameworks, CoA review protocols, and vendor qualification reports to ensure GMP-compliant, traceable raw material sourcing for both APIs and functional excipients.
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Evaluation of Existing Formulation for Cost Reduction
Systematic gap analysis of current formulations to identify excipient substitution opportunities, process simplifications, and batch size efficiencies — without compromising quality or regulatory status.
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Ready-to-Compress Granules/Pellets
Wet granulation, dry granulation, and pelletization development with blend uniformity, flowability, and compressibility optimization. Scale-up and transfer documentation included.
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Stability Studies (ICH/Regulatory Guidelines)
Real-time and accelerated stability protocols per ICH Q1A(R2) — 25°C/60%RH, 30°C/65%RH, 40°C/75%RH zones. Includes degradation profiling, shelf-life determination, and regulatory-ready reports.
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Dossier Preparation and Regulatory Filing (CTD/eCTD)
Module 1-5 CTD compilation and eCTD-formatted submissions for FDA 505(b)(2), EMA MAA, CDSCO NDA/ANDAs, and WHO PQ dossiers. Pre-submission review support included.