Registration Strategy in US, EU & Emerging Markets
Regulatory Feasibility Analysis
Strategies for product Filing and Variation
Advisory on CMC data generation for successful filing
Change Control Strategies
Subject Matter Expertise
Strategy for Query Responses
Any sound regulatory strategy stands on effective planning and implementation. Regulatory Operations by way of New Filings, dossier compilations or variations, running procedures on client’s behalf, regulatory due diligence etc form the heart of Regulatory Affairs. We at Cuckos have made a name for us, to run regulatory operations effectively and with top class quality for our clients.
Services include
Dossier Compilation for Emerging Markets/EU/US/Australia
Types – ECTD, ACTD, National Filing
PIL User Testing
Labelling Reviews as per National requirements
CPP Reviews
API Related
DMF Review
API filing with EDQM for obtaining CEP
Assessment/Review and filing of Amendments / Variations
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