Our focus is to acquire speedy regulatory approval to enable clients to conduct clinical trials in India, covering new drugs, FDCs, investigation drugs, biological products (vaccines, peptides, recombinant products, stem cells, etc.), or devices.

For Clinical Trials in India

Regulatory permission from DCGI to commence clinical trials for phases I, II and III.

  • Import/export licence approval from DCGI
  • Approvals, Notifications or No-objections for Protocol Amendments
  • Notifications of documents such as ICF, SAEs, etc.

New Drug Approval (NDA)

We offer a one-stop solution for formulations, API, FDCs, new indication, new dosage form, modified release dosage form, ayurvedic, nutraceuticals, veterinary and cosmetics.

Our team is extremely competent in developing the appropriate dossier for any new drug approval. We can also provide clinical trial management services and bioequivalence study services at very competitive rates.

We work extensively in collaboration with CROs who can provide cost-effective animal toxicological studies and stability studies services. We also provide complete method validation protocol to final report (with chromatograms) for regulatory submission.

Toxicity studies services include:

  • Acute Toxicity
  • Sub-chronic Toxicity
  • Chronic Toxicity / Carcinogenicity
  • Teratology Studies, etc.

Format and Guideline:- As per country specific guideline

We can obtain DCGI approvals for the following:

  • New Drug Formulations
  • Biologicals (vaccine, recombinant products, peptides, stem cells)
  • Fixed Dose Combinations (FDCs)

Rationale and Justification: The success of any new FDC largely depends on the rationale and justification for combining the individual ingredients together. In line with the new regulations at CDSCO, all cases of FDCs are discussed by the NDAC expert committee in the presence of the sponsor before granting approval. We have the capabilities to design and prepare a sound rationale for each FDC, and can also represent the sponsor at the NDAC meeting.

Consultancy and Strategy Development of Approval of FDCs: Once you inform us of an FDC, we will provide all technical support – from dossier development right through to product approval.

Medical Literature support for FDCs: Our team can help you find medical literature for proposed combinations, as well as other specific literature to support your combination in terms of pharmacodynamic and pharmacokinetic interactions.

API (Bulk Drug): We can assist pharma companies in sample analysis, testing and certification from CDL, CIPL and CDTL.

Licences & Registration

  •  Manufacturing
    We can assist in obtaining a manufacturing licence for LVP/Vaccine/SERA in collaboration with CLAA, State FDA and Zonal offices.
  • Import (Form 10)
    We can assist in obtaining import licences for:
    • Bulk drug & finished formulations
    • Biologicals
    • Medical devices
    • Diagnostic kits (both critical and non-critical)
    • Cosmetics 
  • Registration:
    On your behalf, we can register the following products at CDSCO:
    • Bulk drug & finished formulations
    • Biologicals
    • Medical devices & critical diagnostic kits
    • Cosmetics

Test Licence:
We can obtain a test licence for all kinds and classifications of products.


Narcotics:
We can assist in obtaining an Export No Objection Certificate (NOC) for Narcotics.

Embassy Attestation:
We can arrange the Ministry of External Affairs Embassy attestation and subsistent Embassy Attestation for relevant countries.

Academic Trial Approval:
We offer the service to speedily obtain approval for the commencement and undertaking of an Academic Trial in India.