Regulatory Consultants

A well prepared submission can save time and money, reducing the number of subsequent questions from Assessors and reducing the time to market.

Our regulatory affairs consultants can assist you with regulatory submissions for Clinical Trial Applications and Marketing Authorisation Applications. All our regulatory consultants have extensive experience in regulatory affairs on numerous submissions, covering all procedures: National Procedure, Mutual Recognition Procedure (MRP), Decentralised Procedure (DP) and the Centralised Procedure (CP).

iRegulatory is a pharmaceutical consultancy with extensive drug regulatory affairs knowledge. Regulatory submissions are developed using our in-house regulatory consultants and supported by the iRegulatory Panel, a group of external consultants with whom we have strong working relationships.

As regulatory consultants, we have assisted clients with:

• Advice on regulatory strategy
• Preparation for scientific advice meetings with regulatory authorities
• Clinical trial applications
• Regulatory writing
• Preparation of responses to questions
• Maintenance activities, including variation and renewal applications

We have particular expertise with preparing Module 2 clinical and non-clinical summaries and overviews.

Our in-house publishing capability also allows us to prepare your regulatory submissions in all eSubmission formats.

If you require any assistance with regulatory submissions from our experienced regulatory consultants, please contact us, at no obligation.