SERVICE OVERVIEW REGULATORY AFFAIRS

Nuvisan provides a wide range of regulatory services to the pharmaceutical industry.

• Regulatory Support to Clinical Trials, 
including IMPD preparation

• Special Regulatory Issues

• Regulatory Strategy and Development Planning

• Preparation of Application Dossiers

 

YOUR BENEFIT

• Significant experience with a wide range of product types, including 
  “small molecules”, herbal preparations and biotechnology products

• Knowledge and experience in Scientific Advice Procedures, Clinical Trial 
  Applications (CTA) and Marketing Authorization Applications (MAA)

 

REGULATORY SUPPORT TO CLINICAL TRIALS

• IMPDs: Preparation of Investigational Medicinal Product Dossiers, review, 
  and gap analysis

• Preparation and submission of Clinical Trial Applications (CTAs) to 
  Competent Authorities and to Ethics Committees

 

SPECIAL REGULATORY ISSUES

• E.g. Scientific Advice: 
Preparation and submission of requests for scientific 
  advice/protocol assistance, including meeting management, participation 
  and follow-up

 

STRATEGY AND PLANNING

• Regulatory strategy consultation

• Development planning

• Expert review of scientific documents including gap analysis

• Interpretation of regulations and guidelines

 

PREPARATION OF APPLICATION DOSSIERS

• Compilation of application dossiers in the Common Technical Document 
  (CTD) format

• Preparation of expert reports, overviews and summaries, summary of 
  product characteristics, patient information leaflets, labelling, and 
  application forms

• Follow-up activities such as preparation of responses to regulatory 
  agencies, e.g. answering deficiency letters

 
 
 

Contact

Business Development
Please send us an Email!



Exhibitions

CURIOUS 2018
Future Insight Conference
16.07. - 18.07.2018
Darmstadt / Germany


CPhI Korea
Mix the world of Pharma products, People & solutions
28.08. - 30.08.2018
Seoul / South Korea


BioFit
7th edition
Fostering Innovation & Transfer
04.12. - 05.12.2018
Lille / France