AKP

Regulatory Affairs

AKP is able to provide regulatory support for Phase II – IV trials, non-interventional and Medical Device studies.

We ensure that all regulatory activities are of highest quality and compliant with the national regulations.

Our services include but are not limited to:

• Consultancy regarding study design, clinical development planning and submission requirements
  
• Medical Writing and / or document reviews: protocols, observational plans, amendments, patient’s information / Informed Consents, investigational product labels, etc.
  
• Preparation and management of clinical trial applications to Regulatory Authorities
  
• Programming of electronic Case Report Forms
  
• Submission to Ethics Committees
  
• End of study and outcome reporting
  

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