Whatever you need for market entry to virtually any country worldwide
List of available categories
Healthcare Regulatory Affairs Service
- Pharma
- Pharmaceuticals
- BioTech
- Vaccines
- Biologics
- Biosimilars
- Orphan Drugs
- Medical Devices
- Medical Equipment
- Lab Equipment
- GMP
- Disinfectants
- Cosmetics
- Cosmeceuticals
- Nutrition
- Supplements
- Vet
- Food Health Claims
List of available service and territories
Expediting your needs
- Regulatory Affairs
- Regulatory Strategy
- Cost Estimation
- Regulatory Intelligence
- Gap analysis
- Regulatory Compliance
- Regulatory Operations
- Regulatory Procedures
- Current Legislation
- Local regulations
- Market Entry Consulting
- Intellectual Property Rights
- Legal support
- Legislation
- Pre-submission
- Application
- Market Authorization
- Approval
- Renewal
- Variation
- Pharmacovigilance
- EUA
- Health Claims validation
- Conclusion
- RA Project Management
- RA Global Network
- RA Backlog Projects
- Pre-marketing Notification
- Pre-marketing Clearance
- Authorization
- Product Permission
- Free Sales Certificate
- eCTD, CTD
- Technical dossiers
- DMF, DMFs
- Registration Dossier
- Leaflet
- Labeling
- Instruction
- Translation
- Braille font
- Safety assessment
- QMS, QA, ISO
- Establishment Registration
- GMP Recognition
- GMP Certificate
- GMP Conclusion
- GMP for PIC/S
- GMP for FDA
- Regulatory Authorities
- State Authorities
- FDA
- EPA
- Pharma
- Investigational New Drug (IND)
- New Drug (NDA)
- Biologic License (BLA)
- Abbreviated New Drug (ANDA)
- Over-the-Counter (OTC)
- Pharmaceuticals
- Original Drugs
- Generics
- BioTech
- Biologics
- Biosimilars
- Orphan drugs
- API
- Cosmeceuticals
- Cosmetics
- Food supplements
- Medical devices, Class 1-3
- Medical equipment, Class 1-3
- Medical products, Class 1-3
- Lab equipment
- Nutrition
- Substances
- Vet products
- CBER
- USDA
- EMA
- MHRA
- Territories:
– US | HQ
– UK
– EU
– Switzerland
- Middle East
- Central Asia
- CIS countries
– Armenia
– Azerbaijan
– Belarus
– Georgia
– Kazakhstan
– Kyrgyzstan
– Moldova
– Russia
– Tajikistan
– Uzbekistan
– Ukraine | HQ
- Latin America
- CIS
– Local Regulatory Authority
– SEC – State Expert Center
– MOH Ministry of Health