Episteme’s Regulatory team offers expert guidance and submission support throughout the entire product development and launch process . With over 100 years of cumulative experience, we meticulously plan and coordinate every aspect of a clear and complete submission. Our extensive regulatory and scientific expertise, allows us to optimize the submission process.We provide consulting services for key regulatory submissions for US,EU,CA and AUS, including:Investigational New Drug Applications (INDs): Support for pre-IND meetings, preparation, and submission.New Drug Applications (NDAs) and Assistance throughout the preparation, submission, and review to ensure timely approvals.Abbreviated New Drug Applications (ANDAs): Expertise in generic drug submissions, bioequivalence studies requirements , and Labeling Reviews,Regulatory Strategy Development: Customized strategies to navigate regulatory pathways and mitigate risks.Post-Approval Compliance: Ongoing support for maintaining compliance with the post-marketing requirements.Our deep knowledge help streamline the regulatory process, ensuring your product reaches the market efficiently. Whether in early development or preparing for launch, Episteme’s Regulatory team is here to provide the expertise and support you need for success.

• Heading US and other advanced markets (EU,AU,CA, IL, JP) regulatory team of 50 + people (CMC and labeling).• Have been instrumental in submission of 300 + ANDA/NDA for US markets and securing approval of 190+ applications• Regulatory strategy, trouble shooting and debottlenecking at all stages, right from product identification, development to approval.• Efficient life cycle management, active support to manufacturing locations for change management and ensuring business continuity.• Supporting cross functional teams and active involvement in meetings with senior management for complex regulatory matters and facilitating decision making .

• Submission of application for US, Australia and New Zealand.• Review of documents and authoring application• Co-ordination with cross functional teams for documents required for submission• Setting-up new analytical development lab for US and other regulated markets• Method development and validation.

• Section head for raw material and microbiology • Institutionalize new plants quality control department, setting and ensuring GMP compliance• Successfully undergone audits from TGA Australia, UK MCA and MCC South Africa

• Physicochemical and instrumental analysis of raw materials, in-process samples and finished drug products• Documentation work for ISO, WHO certifications.• GMP compliance and documentation

Physicochemical and instrumental analysis of raw materials, in-process samples and finished drug products• GMP compliance and documentation• Microbiological testing of raw materials, drug product, sterility testing, environmental monitoring of parenteral and oral solid manufacturing facility