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!

 

 

Dr. Sylvie Bruchmann
Vice President

James Dickinson
Global Head 
of Clinical Services

Dr. Christian Reh
Chief Medical Officer

Dr. Florian Schwaak
Director 
Business Development