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22/07/2017
"Risk minimization in data anonymization process"

Come and join us in Barcelona for the 2016 PhUse annual conference. ...

22/07/2017
“The new biosimilar market” / « Le nouveau marché des biosimilaires » - The 7th annual conference of DII.

“The new biosimilar market” / « Le nouveau marché des biosimilaires » - The 7th annual confer...

22/07/2017
Afcros - “Clinical Research Day”.

Afcros - “Clinical Research Day” - January 26,2017...

22/07/2017
[Conference] Meet Keyrus Biopharma at the "IFB eHealth Day 2017: patient health data in policy and research"

[Conference] Meet Keyrus Biopharma at the "IFB eHealth Day 2017: patient health data in pol...

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Our Know-How

Regulatory Affairs

The development and the launching of a new pharmaceutical product may take up to 15 years. During the scientific and the development processes as well as the clinical investigations and the marketing authorization many problems may arise due to the changing, evolution of the regulatory environment but also to the different interpretation by the local regulatory agencies.

 

The Regulatory affairs department of Keyrus Biopharma helps the pharmaceutical and the biotechnology firms to overcome these issues. The department provides high level of technical and strategic advices right from the beginning of the development, during the different clinical trial phases, for the marketing authorization process and the life cycle management of the product.

Within a competitive world, the reduction of the time taken to bring a product to the market is critical for the company’s success. Thus, the proper conduct and the optimization of the regulatory activities is an asset for the company’s growth and economy. Our approach will play an important part in coordinating scientific knowledge with regulatory requirements throughout the lifecycle of the product, helping the companies to maximize their cost-effectiveness and return of investment.

Our valuable scientific and regulatory expertise based on the experience of our Ph.D., MD and Pharm. D. members within the pharmaceutical, biotechnology and medical devices fields have been important to develop solutions and set up regulatory strategies to answer the client´s needs in every stage of the product development.

 
Our regulatory affairs team ensures mainly:
  • Proposing and executing the right regulatory strategy that answer your needs and satisfy the authorities.
  • The preparation, the compilation and the submission of different regulatory documents (CTD, Authorization for clinical trials…) for the national procedures or VHP concerning clinical trials, and for a national procedure, DCP, MRP or CP concerning the marketing authorization.
  • An operational support for the writing of the regulatory documents in collaboration with our Medical Writing department to ensure the compliance and to respect the local specific requirements.
  • The revision and the quality control /compliance of the regulatory documents.
  • Answers to the different questions issued by the different regulatory authorities.
  • Regulatory representation and support to our clients at different professional meetings in order to defend their interests by presenting both written and oral evidence before the panels
  • Renewal of marketing authorizations and product´s lifecycle management
  • The design of the Pediatric Investigation Plan (PIP)
  • Being aware about the regulatory changing environment  in order to propose new scenarios of adaptation and even new orientations for the product’s strategy.
  • Advices on the commercial/advertizing legal requirements 
Our expertise covers:
  • First to market products
  • Biological (e.g. vaccines) and therapeutic products (e.g. Cell, gene therapy))
  • Medical devices and in vitro medical devices
  • Biosimilars