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Atop Pharma Solutions
Your partner for all regulatory and translation solutions
+91 98981 24444info@atoppharmasolutions.com
- Home
- 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
- Trademark
- Copyright
- Patents
- Contact