CHINESEOur Services
MA duplication procedure
MA duplication procedure
MA duplication procedure
We take care of duplication of the authorization obtained for one region to the other regions as per the regulatory requirements of the specific countries.
Atop Pharma Solutions
Your partner for all regulatory and translation solutions
+91 98981 24444info@atoppharmasolutions.com
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- About Us
- Regulatory Services
- Regulatory due diligence and strategy
- Gap Analysis
- MAA dossier – review and compilation of modules 1 to 5
- eCTD/NEES publication services
- Product information preparation – SPC, PIL and Labelling
- Readability Testing and Bridging report
- Translation of pharmaceutical documents
- Local regulatory support
- Deficiencies management
- Lifecycle maintenance: variations (Type IA, IB, II), renewal, and MA transfer, ‘sunset clause’ exemptions package, withdrawal
- MA duplication procedure
- Regulatory services for specific countries e.g. LATAM, CIS + ex members, ASEAN, South Africa, ANZ, Botswana, Switzerland, etc.
- Pharmacovigilance
- Signal detection
- Drafting and submission management of PSUR, PBRER, PADER, Clinical Overview and DSURs: Comprehensive Pharmacovigilance Service packages for ROW region
- Establishment of PSMF and drafting of Risk management plan
- Literature search -Global/local literature search and review for reports of adverse events for all types of products, using standard terms
- Monitoring of literature for aggregated reports and safety information
- Scientific and medical writing: Drafting of Clinical/Non-clinical report or overview, narrative, IMPD with all regulatory compliance of EMA/any country
- Translation
- Toxicology
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