Strategies for Pharmaceuticals Product Development in Regulated market
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Stage 1: Literature Search


.Literature Research:
USP, BP, Pharm. Eur, PDR, Martindale, Merck, Florey, Vidal

.FDA: Summary Basis of Approval

.On-line computerized search

.FDA CDER: Evaluation of Biostudy parameters, Dissolution methods.

.Patent evaluation: Orange Guide + FDA CDER


Stage 2: Active Sourcing


Sourcing for Active Raw Material:
International Suppliers US, European, Asian,

- Review suppliers catalogues & data critically.

Potential Suppliers List:
Request samples and C of A and Specifications,
Evaluate at least two suppliers fully.

Stage 3: Active Evaluation


Evaluate Potential Actives:
Evaluate at least two to three potential active suppliers
• DMF availability
• Compliance with Pharmacopoeial monograph
• Impurity profile and stability
• Potential Polymorphic forms
• Commitment for physical specifications
• Statement of non-patent infringement