Comprehensive Regulatory Services
Regulatory Affairs Strategy
- Regulatory
Support (CTA, import/export permits, GMP auditing, etc.)
- Labeling
- Translations
of Technical Documents
- Coordination
of Regulatory Certificates
- Assessment
of the Appropriateness of the Existing Documentation for an Approval in
the Target Countries
- Regulatory Strategy Development
Regulatory Requirements & Dossier
Preparation
- Clinical Trial Applications
- Marketing Authorisation Applications
- Variations
- Renewals
- Legal Status change
Registration
Procedure/Regulatory Management
- National Applications
- Regulatory support during the assessment
- Appeals
Liaison with National Regulatory Authorities
Non-commercial Local
Marketing Authorization Holder
Regulatory
Development & Maintenance of Marketed Products
- Changes to CMC
(Chemistry, Manufacturing, Control)
- Labeling Updates
and Harmonization of Labels
- Product Transfers
- Company Mergers
- Coordination of
Regulatory Certificates
- Special Projects
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Categories of Healthcare Products- Pharma Drugs (New Chemical Entities & Generics)
- Medical Devices
- Herbals & Food supplements/Health supplements
- Cosmetics and Nutricosmetics/Nutraceuticals
- Over-the-counter (OTC) products
- Biologicals, Biotech & Biosimilars
Contact us to know more about our wide range of Regulatory Services. |
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