Clinical Regulatory India

Our Services

Helping healthcare and research teams navigate regulatory and academic challenges.

CDSCO Regulatory Guidance

Support for CDSCO regulatory documentation, ethics committee processes, and audit compliance preparation for research institutions.

DHR Registration Support

End-to-end support for Ethics Committee DHR registration, including documentation preparation, portal submission, uploading required documents, and guidance until grant of registration.

Support for research and academic documentation including research topic selection, synopsis and protocol preparation, literature review guidance, research methodology planning, thesis and dissertation preparation, ethics committee submission documentation, and support for DNB and DrNB thesis and research requirements.

Research Protocol & Academic Support

End-to-end support for establishing and preparing an Ethics Committee for NABH compliance, including committee setup, SOP development, documentation preparation, member training guidance, meeting documentation, and audit readiness from initial setup to final compliance review.

NABH & Ethics Committee Support

FAQs

What services does Clinical Regulatory India provide?

We provide professional guidance for DHR registration, CDSCO regulatory processes, Ethics Committee setup and compliance, SOP development, NABH documentation support, clinical research documentation, and academic research support including protocol and thesis preparation.

Do you provide end-to-end support for DHR and CDSCO registration?

Yes. We assist with the complete process from documentation preparation to portal submission and query response for DHR registration and CDSCO Ethics Committee registration, including gap assessment and regulatory documentation guidance.

Help in making your Ethics Committee audit-ready?

Yes. We support institutions in preparing audit-ready Ethics Committees as per NDCT Rules and ICMR Ethical Guidelines, including SOPs, logs, forms, archival systems, member documentation, training guidance, SAE/AE reporting processes, and compliance gap assessment.

Do you provide NABH and SOP documentation support?

Yes. We develop and review audit-ready SOPs and NABH compliance documentation, aligned with ICMR guidelines, ICH-GCP, CDSCO requirements, and NABH standards, including pre-audit gap assessment and compliance preparation.

Do you support research protocol and thesis preparation?

Yes. We provide guidance for research protocol development, clinical research documentation, thesis preparation, literature review structure, and research methodology support for students, investigators, and institutions including submissions under Dr. A.P.J. Abdul Kalam Technical University, DNB, and other academic programs.

FAQs

What are timelines?

We usually respond within 1 hour during working hours.
For urgent assistance, contact: 8285115277

What information is needed?

We generally require basic project or institutional details, relevant documents, and your specific objectives to guide documentation and regulatory processes.

Do you offer remote support?

Yes. We provide remote consultation and document review, accept Word, PDF, and Excel files, and handle all information with strict confidentiality.

Which document formats?

We accept Word, PDF, and Excel files for all submissions.

Is information confidential?

Absolutely, all client information is handled with strict confidentiality.

Feedback

What our clients say about us

Clinical Regulatory India made the entire regulatory process smooth and straightforward, saving us valuable time and effort.

Dr. Mehta

Mumbai

Their detailed guidance on SOP development helped our research site maintain compliance with ease and clarity.

Ms. Sharma

Delhi

★★★★★

★★★★★

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