Regulatory Consulting

Well versed in biopharmaceutical, medical device, and diagnostic regulations, Innovate Research experienced team of former regulatory investigators and quality professionals offer time-tested solutions for companies of all sizes.

We develop practical, tailored plans that align global quality capabilities with business strategy, understanding that preemptive compliance and effective crisis management are critical to a smooth, successful product journey.

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.

Key Regulatory Services

  • Application for an Ethics Committee opinion
  • Clinical trial application to National Health authorities for conduct of clinical trial
  • Effective communication with regulatory authorities
  • Selection of coordinating investigator
  • Regulatory consultation of development programs
  • Assessment and evaluation of dossiers for regulatory subVision & Mission
  • Preparation and compilation of regulatory submissions and protocols
  • Assistance with IEC approval for the studies: Preparation of regulatory package and submission to IEC, assistance to PI in responding to IEC queries and follow-up for timely approval
  • Assistance with independent review boards/ ethics committees approvals

 

Contact

Within India

0 120 4797021

Outside India

+91 120 4797021

G-07, Newbridge Business Centre, 1st Floor,
Inox Tower-B, Plot No. 17, Sector-16A, Film city,
Noida, India 201301

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