Global Drug Regulatory Affairs
Drug Regulatory Affairs
The key to fast regulatory approvals for clinical trials is based on understanding the ever-changing global and local regulatory landscape, combined with ongoing professional relationships with regulatory personals in each country.
Mediclin Clinical Research Drug Regulatory Affairs has both. Our regulatory team is constantly monitoring the regulatory environment of the global pharmaceutical and biotechnology industries, keeping track of changes in all local legislation, guidelines and regulations.
Regulatory Statergic services
- Regulatory Consulting and Strategic services
- Product wise Regulatory Submission Strategy notes
- Pre-submission meetings/Scientific advices
- Regulatory submission pathways
- Dossier preparation for NDA/ANDA/NDS/ANDS
MAA(CP/DCP/MR/NP) - Regulatory Compliance, Gap Analysis and remediation activity
- Post-Approval Changes Submissions
- Guidance for Nitrosamine report preparation/ review
- Drug Master File (DMF) Submissions
- Investigational New Drug (IND) Applications
- Drug Master File (DMF) Submissions
- Active Substance Master File (ASMF) Submissions
- 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
Labeling services and artwork management
- Regulatory labeling- New submission/ responses/post-approval management
- For US market
- For Canada market
- For Europe market
- For RoW countries
- Structure product labelling (SPL) submissions
- Packaging services and artwork management
- Artwork lifecycle coordination
- Artwork management services
- Artwork proofreading/ quality checks
- Promotion material labelling review
Merger and acquisition facilitation services
- Regulatory support for smooth transition of application
- Project management services
- Strategic consulting
Post-approval change management services
- Supplements preparation and submission
- Variations
- Annual reports
- Renewals
- Change control management
- PADER and safety report submission
Publishing and submissions
- Global eCTD publishing and submission services
- Non-eCTD electronic submissions (NeeS)
- Structure product labelling (SPL) submissions
- Self-identification, BNCC and Establishment registration