Regulatory filling Support
Pre-Filing Activities
1. Regulatory Strategy : To define the regulatory pathway and filing requirements.
2. Developmental Aspects : Controlled Correspondence Submission; Pre-submission meetings; Product development meetings.
3. Controlled Correspondence Submission : To seek FDA’s advice for the intended requirements.
4. Pre-Submission Meeting: Meet with regulatory authorities to discuss the alternate pathways and to know the requirements for complex products.
5. Product Development meeting: Meet with regulatory authorities to discuss product submission requirement for complex products including Clinical, Non-clinical and CMC data
6. Quality Management: Ensure that all data and documents meet regulatory requirements and are of high quality.
Filing Category:
1. NDA (New Drug Application): For new chemical entities or new formulations.
2. ANDA (Abbreviated New Drug Application): For generic versions of approved drugs.
3. IND (Investigational New Drug): For new drugs or formulations in clinical trials.
4. PAS (Prior Approval Supplements): For major changes post approval
5. CBE (Change Being Effected : CBE-0 and CBE-30) : For moderate changes post approval
6. AR (Annual Report) : For minor changes to be reported annually.
7. Post-Marketing Surveillance: Monitor the product’s safety and efficacy in the market.
Submission Process:
1. Submission: Transmission of submission package of FDA compliant documents to seek approval.
2. Review: Regulatory authorities review the filing package to ensure compliance with regulations.
3. Deficiency Response : To respond deficiencies issued during review phase within stipulated time.
4. Approval: Upon approval, the product is granted marketing authorization.
This is a high-level overview, and specific requirements may vary depending on the region, product type, and other factors.