Regulatory Affairs

Regulatory Affairs

At Ecron Acunova, the Regulatory Consultant Group is experienced in the development of clinical development planning, positioning strategies, integrated planning, management, preparation of dossiers as well as submission to regulatory authorities and ethics committees for a smooth approval process.

We assure compliance with ICH GCP and relevant national/international regulations. By checking and completing the national/international procedures and approvals (e.g. with bilingual standard form for EC vote, translation of application and approvals etc.) the ICH requirements are met and sponsors are provided with all documents requested for filing and submissions.

Our regulatory experts are experienced in effective and diplomatic liaison with the concerned committees to support you on a wide variety of issues. We ensure fast turn-around on regulatory documents and represent/ support you in meetings with regulatory agencies, for scientific advice.

As your partner, we obtain authorization to conduct studies in countries within individual regions for the import of clinical trial supplies and export of samples. Hence as your advisors in providing up to date guidelines for submission, our experts are also invited to serve on industry and regulatory advisory panels bringing credibility to the submission.
Some of the key areas of support include:
  • Application for an Ethics Committee opinion
  • Clinical trial application to National Health authorities for conduct of clinical trial
  • Selection of coordinating investigator
  • Regulatory consultation of development programs
  • Assessment and evaluation of dossiers for regulatory submission
  • Preparation and compilation of regulatory submissions and protocols
  • Assistance with independent review boards/ ethics committees approvals
  Regulatory Strategy for US FDA
Value proposition we offer:
  • Regulatory experts with strategic consulting in over 60 studies with foreign patients.
  • 505 b 2 application strategy with FDA.
  • Type B meetings with successful defense of strategy
We have in depth expertise with requirements of US FDA, European Regulators and Indian regulatory authorities, related to clinical development.
Regulatory Affairs
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