Drug Regulatory Affairs

Our services in this area are:

Regulatory assessment

• Submission strategy: OTC, medicine, food supplements
• Suitability of claims
   

Documentation

• NTA 2B-CTD modules 1-5 for registration submission
• Reformatting of NtA98 dossier in CTD
• Drug master file for API
   

Regulatory submission

• Consultancy before submission of dossiers
• Support for interaction with health authorities, organisation of hearing
• Coordination of responses to deficiency letters

Regulatory maintenance

• Maintenance and renewal of registrations
• Management of variations
   

Regulatory intelligence

• Continuous maintenance and development of legislation know-how