Regulatory Affairs

Regulatory Affairs Services by Nepgen Clinical:

At Nepgen Clinical, we pride ourselves on providing comprehensive Regulatory Affairs services, ensuring a seamless transition from exploratory to confirmatory stages of investigational drugs. Our dedicated team is committed to facilitating efficient and expedited submissions, potentially accelerating the drug development process for our clients.

Key Offerings:

  1. Smooth Transitions:
    • Navigate the complexities of transitioning from exploratory to confirmatory stages with our expertise, ensuring a streamlined and efficient process.
  2. Expedited Submissions:
    • We specialize in expedited submissions, strategically designed to accelerate the development timeline of investigational drugs.
  3. Facilitated Approval:
    • Our team is dedicated to facilitating the approval of applications to conduct clinical trials for novel drugs, ensuring compliance with regulatory standards.
  4. Agency Collaboration:
    • Benefit from our support and active participation in meetings with regulatory agencies, fostering effective communication and collaboration.
  5. Information Requests:
    • Addressing information requests from regulatory entities is a crucial aspect of our services, ensuring timely and accurate responses for a smooth regulatory process.
  6. GCF Training:
    • We provide mandatory Good Clinical Practice (GCP) training, ensuring that all stakeholders are well-versed in the ethical and quality standards of clinical research.
  7. Study Protocol:
    • Our experts contribute to the development of comprehensive study protocols, aligning with regulatory requirements and industry best practices.
  8. eCRF Design:
    • Tailored electronic Case Report Form (eCRF) design to capture essential data accurately and efficiently during the clinical trial process.
  9. Protocol Modifications:
    • Manage protocol modifications seamlessly, ensuring compliance with evolving study requirements and regulatory standards.
  10. ICF Translation and Version Control:
    • We handle Informed Consent Form (ICF) translation and version control, ensuring clarity and consistency across different language versions.
  11. Ethics Committee (ERB) Support:
    • Facilitate the submission, amendment, and approval follow-up with Ethics Committees (ERB), ensuring ethical considerations align with regulatory expectations.