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 Regulatory
Regulatory Affairs know-how
CMC compliance management
End-to-end lifecycle oversight aligned with ICH guidelines
Dossier
generation
Preparation of IND, NDA, ANDA and global submission packages
FDA and Health Canada eCTD submissions
Validated electronic submission publishing and delivery
Regulatory agency liaison management
Structured communication with regulatory agencies to streamline submissions and review interactions
Inspection readiness and response management
End-to-end inspection preparedness and regulatory response coordination to ensure compliance confidence
Post-approval management
Ongoing regulatory lifecycle management to mantain compliance after product approval
Compliance & Certifications
Development conducted under Good Laboratory Practices
Manufacturing performed in GMP-compliant facilities
Manufacturing sites registered with the FDA and authorized by the DEA
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