Global Drug Regulatory Affairs
Drug Regulatory Affairs
- Regulatory Approval for Clinical Trials
- Understanding global and local regulatory landscapes.
- Maintaining professional relationships with regulatory personals.
- Monitoring global pharmaceutical and biotechnology industries.
- Tracking changes in local legislation, guidelines, and regulations.
- Partnering with clients to develop customized clinical programs.
Regulatory Strategic 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) submission
- 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
