Team of highly efficient specialist deals with complicated requirements for preparation and submission of Product Dossier to competent authorities for securing Marketing Authorisation.
We provide local regulatory expertise to ensure the smoothest launch of the product. Selection of most appropriate procedures for registration, submission of dossier, monitoring the registration process, scientifically support the company in discussion with registration agency and also in development of business strategy to gain shortest registration timeline and product launch.
Product Registration include:
- Dossier in eCTD or NeeS format
- Registration Procedure via National MRP, DCP, CP
- Preparation/ Verification and Submission of Registration Dossier to Authorities
- Post-registration variations management
- Marketing Authorization Renewal Process Management
- Caring for Patients’ health and safety, pharmacovigilance is a key issue for Synoptis Pharma
- We act in line with the appropriate procedures and guidelines laid down by EU Commission
- Our personnel collects, assesses and draws conclusions from the possibly reported adverse drug reaction to constantly monitor the benefits-risk ratio of our medicinal products