Services

Clinical Regulatory

We are actively providing hands-on support of Clinical Trial submissions throughout Europe for both Competent Authority and Ethics Committee approvals.

We provide regulatory operational oversight activities for CTs for trial phases I through III for a number of clients currently in global markets ex US and Canada, incorporating all EU countries, and other diverse blocks including South America, Middle East, Asia, and South Africa.

  • Advice on clinical trial authorisation (CTA) submission strategies
  • Advice on using the Voluntary Harmonisation Procedure for CTA submission in multiple EU countries
  • Support internal teams by clarifying and providing advice on current and planned regulatory legislation and guidance
  • Provide detailed country requirements for CTA applications
  • Act as regulatory affairs representative on project teams
  • Review or author  key submission documents like IMPD, IB, Protocol in compliance with EU requirement
  • Prepare core CTA submission packages including cover letter, EudraCT form, any required declaration
  • Finalise and effect CTA submissions to Competent Authority and Ethics Committee
  • Managing regulatory oversight of CRO activities including quality control of submissions
  • Interaction with regulatory agencies to seek advice, agreement, and approval to run the trial
  • Provision of issue-focused regulatory support throughout the entire lifecycle of the trial
  • Escalation of any regulatory issues of key importance
  • Regulatory sign off on-site release packages
  • Support and participate in GxP agency audits
  • Draft and input to RA Clinical Trial related SOPs
  • QC process for submission and determining substantial/non-substantial amendments
  • Advice on information to be made public for a clinical trial
Contact

What our clients say