Four sites in Pune likely to be part of human clinical trials of Oxford Covid-19 vaccine
Regulatory
Support
JCDC is engaged in providing complete regulatory guidance and support for Drugs, Biological Products & Medical Devices submissions to regulatory agencies including US FDA (Food and Drug Administration), EMEA (European Medicines Evaluation Agency), UK MHRA (Medicines and Healthcare Products Regulatory Agency), TGA (Therapeutic Goods Administration), PMDA (Pharmaceuticals and Medical Devices Agency), CDSCO (Central Drugs Standard Control Organisation), ASEAN (The Association of Southeast Asian Nations) and HSA (Health Sciences Authority). We extend our support in the following areas:
- Gap Analysis of the available data for regulatory submission
- Preparation & Submission of Regulatory dossiers as per regulatory guidelines.
- Liaising & Following up with Regulatory authorities.
- Consultation of Drug, Biological Products & Device Regulations
- Global Clinical Trials – Regulatory Submissions
- Common Technical Document (CTD) services, publishing, and regulatory authority submission management
JCDC specializes in providing comprehensive regulatory guidance and assistance for the submission of Drugs, Biological Products, and Medical Devices to esteemed regulatory agencies worldwide. Our expertise extends to collaborating with regulatory bodies such as the US FDA (Food and Drug Administration), EMEA (European Medicines Evaluation Agency), UK MHRA (Medicines and Healthcare Products Regulatory Agency), TGA (Therapeutic Goods Administration), PMDA (Pharmaceuticals and Medical Devices Agency), CDSCO (Central Drugs Standard Control Organisation), ASEAN (The Association of Southeast Asian Nations), and HSA (Health Sciences Authority).
Our support encompasses a wide range of services, including:
We conduct a meticulous assessment of available data to identify gaps that need to be addressed before regulatory submission.
We meticulously compile regulatory dossiers in strict accordance with regulatory guidelines. This includes preparing submissions such as IND (Investigational New Drug), NDA (New Drug Application), Premarket Notification 510(k), Premarket Approval (PMA), De Novo applications, Orphan Drug Designation, and Scientific Advice applications.
Our expertise includes creating comprehensive briefing books and crafting Marketing Authorization applications utilizing Common Technical Document (CTD) services, eCTD formats, and eSTAR formats.
We handle the intricate processes of publishing and managing submissions to regulatory authorities.
We adeptly interact with and follow up on communications with regulatory authorities on your behalf.
We offer expert consultation on Drug, Biological Products, and Device Regulations to ensure compliance and successful submissions.
We assist in regulatory submissions for global clinical trials, including the development of clinical plans.
At JCDC, our commitment is to provide thorough, reliable, and timely support to facilitate the regulatory journey for your products and ensure compliance with international standards.