Regulatory Services
Compliance to Success
Our regulatory services are designed to empower your biopharmaceutical endeavors, from early development to market access, ensuring compliance and success every step of the way.
- Regulatory strategy
- Abbreviated New Drug Application(ANDA) Submissions
- Biologics license Application (BLA) Submissions
- Drug Master File (DMF) Submissions
- New Drug Application (NDA) Submissions
- Investigational New Drug (IND) Submissions
- Post-Approval Changes
- Regulatory Compliance
- Inspection readiness and GxP Compliance
- FDA Communications
- Risk Assessment
- Labeling
- Regulatory Intelligence
- Post-Market support