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Medical Device Regulatory Affairs Consultant


What Are The Services Of Consultants In Medical Device Regulatory Affairs?


The Services Of The Regulatory Affairs Consultant

We are well equipped with the knowledge of all the regulatory procedures that need to be followed by the companies who manufacture medical and pharmaceutical products. The services include guiding the companies for planning, managing, production of both medical and pharmaceutical and most important is to follow all the regulatory recruitment. We have very qualified and competent experts who can conduct their job very efficiently in assisting all the manufacturing companies using the expertise. The guidance is given from the start to the end of the process including the marketing applications. The manufacturers are benefited by the services of our experts of Medical Device Regulatory Affairs.

Preparation Or Review And Filing Of The Dossier (Submission)

  • Packages of Pre-meeting, INDs/CTAs/IDEs, and post-filing submissions
  • BLA/NDA/NDS/MAA/510(k)/PMA filing (US, Canada, EU)
  • Submission and preparation for other worldwide agencies in European countries, South America, Australia, and Asia.

Development Of The Strategies For The Life Cycle Of The Products

The Regulatory Affairs Consultant provides the following services to the manufacturing companies of medical and pharmaceutical products.

  • Consideration of the international regulatory requirements.
  • Meeting the filing of international standard
  • Revision of change of plans and guidelines

General Services Of The Consultants

We assist the interaction with the regulatory agencies like arranging meetings and the conference calls, negotiations while the development stages are going on. Further to this, we help the companies in the submissions and the approval process of the submission. The other services are the liaison with the regulatory agencies in the process of regulatory and chemistry. The professional experts of our consultancy also guide the companies in manufacturing and controlling clinical and toxicology matters. 

Additional Services Of The Consultants

  • Regulatory classification of products across the various jurisdictions
  • Provide expert advice on the regulatory CMC during the complete development.
  • Working with the sponsors and the regulatory authorities by the resolution of complex development problems.
  • Act as US Representative for the submissions of the US and as EU Agent in Europe, and as the Canadian Representative for Canadian submissions.
  • The assistance with complete diligence for the investors and the licensees.