Pharmaceutical Regulatory Affairs Services
Clinical Trials India shares exemplary relations with the Pharmaceutical Regulatory Authorities of India. We assist the pharmaceutical and biotech companies in regulatory submissions for phase I-IV studies and bioequivalence studies.
Pharmaceutical Regulatory Submission Services
We at Clinical Trials India manage and compile your documents required for pharmaceutical regulatory affairs, IND and DCGI submission. The submission involves all the documents containing the details of the new drug and clinical trial. This is followed by DCGI approval to conduct phase-I clinical studies. DCGI approval is a step-by-step process starting from receipt and compilation of documents for IND followed by review by DCGI and ICMR officials, and receipt of test license for import. After the import license is obtained, the protocol is reviewed and the phase-I studies can be started.
Best Solutions
Our pharmaceutical regulatory affairs consultant services offer best solutions to meet all kinds of challenges for pharmaceutical, biotechnology, diagnostics and CRO industries. The pharmaceutical regulatory affairs consultancy helps to overcome hurdles in compliance activities.
The expert pharmaceutical regulatory affairs services involve:
- Registration for vaccine formulations, r-DNA products, blood products and API formulations.
- Registration for medical devices, and diagnostic kits
- New Drug approval for the vaccine formulations, r-DNA products, blood products and API formulations.
- New Drug approval for medical devices, and diagnostic kits
- Approval for phase-I studies of Indian new drug discovery.
- Approval for repeated phase-I studies.
- Approval for phase II, III, and IV studies.
- Safety reports updating.
- Import licenses and permits for commercial and experimental use.
- No objection Certificates for conducting BA/BE studies.
- Export permission/ permit for biological samples from Directorate General of Foreign Trade/ Ministry of Commerce.
- No objection Certificate for the export of banned/ unapproved drugs.
Clinical Trials India is known for working on the most complicated pharmaceutical regulatory issues with the highest level of confidentiality. We analyze your exact requirements and strategize the regulatory pathways on timescale.
With the in-depth knowledge of the regulatory laws and Acts, we deal with the pharmaceutical regulatory affairs of combi vaccines, new r-DNA products, and new medical devices and have been extremely successful in retaining most of our clients.
We feel proud to announce that Clinical Trials India is rated as top pharmaceutical regulatory consulting company in India. Our clientele includes pharmaceutical, medical devices, diagnostics and biotech multinationals, Indian pharmaceutical companies, Contract Research Organizations, Government and semi government organizations.
Fermish looks after the Pharmaceutical Regulatory Affairs of Clinical Trials India
