Regulatory Submissions

At RRG, we have a track record of successful submissions for clinical trials and marketing authorisations across a wide range of therapy areas and types of dossier. With the help of our highly experienced administrative support team, we can prepare submissions of any size, but our service does not stop there. We can manage the whole regulatory process including:

  • Authoring and /or reviewing submission documents
  • Preparing and participating in pre-submission agency meetings
  • Submission compilation – paper or electronic
  • Preparing and coordinating responses to questions
  • Preparing and participating in hearings and appeals
  • Post approval life cycle management including variations, amendments, renewals.

Managing regulatory submissions is one of the largest areas of our work and ranges from a clinical trial application for a Phase I study in a single country through to management of a 29 country Decentralised Procedure! The extent of our involvement is also flexible, from supporting an in-house regulatory affairs department with the logistics of the submission right through to taking complete responsibility for the preparation of the submission and coordination of the regulatory process.

Our extensive experience and wide network of local contacts allows us to negotiate effectively the complexities of the regulatory environment. Whether it's an NCE, a line extension, a new combination product, a generic, an OTC product or a medical device, RRG consultants have dealt with something similar before.

A dedicated consultant will be assigned to your project to provide continuity and develop familiarity with your team and products. We work in partnership with your in-house experts and project team to prepare the submission and to take it efficiently through the regulatory process.

The integration of our submissions service with our product development and regulatory strategy offerings ensures that you not only get your submission in on time but you maximise the chances of getting it approved on time.

Contact Us

T: +44 (0)1276 671 166
F: +44 (0)1276 670 960
info@rrgconsultancy.com

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Find Us

RRG, Innovation House
Albany Park, Camberley
Surrey. GU16 7PL

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