What can we do for you?

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 countrie

– 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