Regulatory Services
We provide end-to-end regulatory consulting for pharmaceutical products, Biological products and medical devices, including submission strategy and dossier preparation, health authority support, and compliance services such as gap analysis, nitrosamine guidance, due diligence, and remediation to improve approvability and market expansion
- Regulatory Consulting and Strategic services
- Product wise Regulatory Submission Strategy notes
- Pre-submission meetings/ Scientific advice
- Regulatory submission pathways
- Dossier preparation for NDA/ ANDA/ NDS/ANDS/ MAA (CP/DCP/MR/NP) and RoW market
- Regulatory Compliance, Gap Analysis and remediation activity
- Guidance for Nitrosamine report preparation/ review
- Investigational New Drug (IND) Applications
- Interaction with Health Authorities
- Product evaluation for Market Extension
- Remediation of Regulatory Deficiencies
- Performing due diligence for products to check product acceptability and approvability
- Medical Devices Regulatory Intelligence
- Fast track services and responses within 24- 48 hours
