|
Regulatory Affairs
MakroCare provides global regulatory affairs expertise to streamline submission management and achieve fast product approval.
Approval Strategy
- Development planning
- Advisory boards
- Agency meetings
- Submission strategy
- Due diligence & data evaluations
- Japanese regulatory strategy & advice
Submission Management
- IMPDs and CTAs
- INDs
- Drug Master Files
- Marketing Authorisations (MAAs, NDAs, BLAs)
- Translations
- Variations and Renewals
Electronic Publishing (CTD and eCTD)
Regulatory Compliance
- Development of integrated Project Quality Plans
- GLP, GMP and GCP compliance audits
- Mock and Pre-Approval Inspections
- Review and assessment of corrective actions
- Design and delivery of Quality System training
- Due diligence in support of in-licensing and out-licensing activities
|
