At QUINTESSENTIAL, 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. Our regulatory experts are experienced in effective and diplomatic liaison with the concerned committees to support you on a wide variety of issues.
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:
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Application for an Ethics Committee opinion
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Selection of coordinating investigator
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Regulatory consultation of development programs
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Assessment and evaluation of dossiers for regulatory submission
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Preparation and compilation of regulatory submissions and protocols
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Assistance with independent review boards/ ethics committees approvals