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Regulatory Services

Expert Regulatory Support Services to Navigate Complex Compliance Requirements, Accelerate Approvals, and Ensure Successful Product Development Lifecycle Management.

Regulatory Services

Regulatory Services is an integral component of our services portfolio. Training at Spoorthy Medical Coding Institute is an opportunity to explore your knowledge and develop innovative skill sets that help in clearing your certification examination in the first attempt itself.

The independent team for regulatory services helps you navigate complex regulatory requirements throughout your product’s development lifecycle. We have an in-depth knowledge of local regulatory procedures and dedicated and effective liaisoning with various regulatory agencies that ensures high efficiency in the Clinical Trial approval process.

In order to receive regulatory approval, you invest significant resources, time and effort in drug development. Never let the intricacies of filing across multiple countries delay your launch. Banking on Spoorthy Solutions' integrated cross-functional expertise and flexible sourcing options, our clients benefit from comprehensive regulatory support services.

Spoorthy Solutions' services include but are not limited to:

  • Offer support on Indian regulatory environment & requirements
  • Compiling dossiers
  • Executing regulatory submissions
  • Preparation & submission of complete range of regulatory documents for obtaining:
    • Approval to conduct clinical trial in India
    • Approval to import Test Drug
    • Approval to export Biological Samples
    • Liaisoning and obtaining registration documents in the interest of clients
    • Continuous follow-up post submission with regulatory authorities
    • Renewal of Import License
    • Safety reporting
    • BENOC - T-license filing
    • NSWS filing
    • SAE reporting on Sugam Portal