Regulatory services 

Regulatory support is crucial to all phases of the product development process. It is affected by up to date guidelines, points to consider, standards, product specific good practices and pharmaceutical and/or medical device engineering regulatory requirements.

Moreover, using the required format and layout for the different submission packages increases successful review, favorable opinion and shorten the time for successful marketing authorization.


Liaison with regulatory authorities represents a significant challenge in the product approval process. Early interactions with the authorities’ staff can help preventing delays in the development plan. It provides information assisting in preparing regulatory applications, especially helpful to small businesses that may have limited experience in interacting with regulatory authorities.


Pharmatrial is a reliable partner that could provide in-depth regulatory support saving you valuable time and money assisting you in fulfillment of the regulatory requirements. Our well established experience and expertise in regulatory affairs, for more than a decade, in a large variety of projects and vast experience in interactions with the regulatory authorities may accelerate the approval process and reduce time to market.

    
Pharmatrial medical writing team offers our clients an extensive portfolio of medical writing, editing and scientific review services as well as preparation, of your company documentation aimed for regulatory submission at any product development stage to any regulatory authorities.


Because of our familiarity with the regulatory authorities expectations we have an excellent reputation for filing high-quality, easily reviewable applications.

Among our customized services:

 

  •  Preparing company team for Pre meetings (simulation)

  •  Pre meetings briefing packages preparation

  • Post meetings comments analysis and responses

  • IND submission

  • Preparation review and submission of eCTD documents

  • Applications submission

  • Advisory committee meetings

  • Annual product reports

  • Responses and warning letters

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Other Services

  • Liaison with regulatory authorities: (Scientific advice meeting, protocol assistance meeting, pre-submission meeting)

  • Expert reports preparation for authorities

  • Liaison with notified bodies

  • Technical file assembling  for CE approval

  • Establishment of quality management system  for ISO certification

 

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