Services - Regulatory Affairs

Our experienced team of regulatory affairs professionals has recent / current experience including:

• Orphan Drug applications - EU and USA
• IMPD preparation / maintenance - EU
• CTA applications - UK, Sweden, France, Germany, Spain, Belgium, The Netherlands, Poland, Czech Republic, Lithuania, Latvia, Estonia and Denmark.
  • Non EU; USA IND and Switzerland
• MAA - EU
• Scientific advice meetings with agencies; EMEA, FDA, UK MHRA, Swedish MPA, French AFSSAPS, Czech authority, Danish authority, German BfArM, Spanish authority, Swiss Medic
• Regulatory due diligence
• Regulatory project management / strategy advice

Regulatory Affairs Summary

• Regulatory strategy
• Due Diligence Evaluation
• Regulatory authority meetings (EU and USA)
• Clinical trial approval applications (EU and USA)
• Marketing Authorisation Applications
• Orphan drug applications (EU and USA)
• Fast Track applications
• Switch applications
• Expedited Reporting of Adverse Drug Reactions
• Medical Device trial approvals