Some of Our Services
PHARMACEUTICAL TRANSLATION, LOCALIZATION &DTP
- Drug Dossier, DMF / ASMF translation for CIS, China, Mexico, Latam and Francophone countries
- Product Information (SmPC, Leaflet and labelling)
- Translation of Medico marketing material
- Localization (Content, Website, Videos)
- Multilingual Voiceover &Dubbing
- Subtitling & Transcription
- Multilingual Desktop Publishing (DTP)
- Interpretation (Simultaneous or Consecutive)
REGULATORY AFFAIRS
- Dossier & DMF gap analysis
- Dossier & DMF drafting
- Scientific advice in EU and USFDA (US Agent)
- Deficiency response (Dossier/DMF)
- Dossier submission management:
1. EU: DCP, National, MRP, Duplicate, CEP, ASMF
2. USFDA: ANDA and DMF (Type I, II, III, VI and V)
3. Canada: ANDS, DINA and DMF
4. TGA, EAEU and GCC
ADMINISTRATIVE & LIFE CYCLE MAINTENANCE
- MA holding in Europe
- Readability Testing &Bridging report
- Risk assessment: Environmental, Elemental, Nitrosamine
- Drafting of SmPC, Leaflet, Labelling
- Artwork Creation for Leaflet, Carton and Blister
- Life cycle maintenance activity:
1. Europe (Dossier/DMF): Variations like Type IA/IAin
2. Type IB, Type II, Renewal
eCTD PUBLISHING (EUROPE, US, AUSTRALIA, CANADA)
- Baseline eCTD creation
1. MAA application EU, Canada, TGA
2. ANDA/NDA dossier publishing for USDA
- Dossier publishing for EAEU region
- CEP DMF publishing
- ASMF publishing
- DMF (Type I, II, III, VI and V) for USFDA eCTD life cycle management
- NeeS to eCTD conversion
GxP & AUDITING
- Plant Mock Inspection (API and Finished product)
- GMP Trigger (EU/USDA/PICS)
- Third Party Vendor Audit
1. API manufacture
2. Finished product Manufacture
3. KSM, Excipient, Packaging vendors
- Computer System Validation
- PDE/OEL reports