Company & Experience

Dr. Manvi Porwal

A Specialist in Regulatory
Affairs & CMC

Dr. Manvi Porwal is a regulatory affairs professional with a rich background in guiding biomedical companies through the intricate pathways of regulatory compliance and strategic planning. Her journey in the realm of regulatory affairs began with a pivotal role at the Paul-Ehrlich Institute (PEI), Germany's Federal Institute for Vaccines and Biomedicines.
During her tenure at PEI, she honed her expertise in regulatory affairs, particularly in the review and assessment of marketing authorization applications, clinical trial submissions, and variations for biological products in the European Union. She played a vital role in scientific advisory meetings and European Medicine Agency (EMA) trainings, where her insights contributed to shaping the regulatory landscape for vaccines and blood-derived products.
Dr. Porwal remains committed to advancing the biomedical industry by ensuring the safe and effective delivery of innovative medical solutions worldwide.

Driven by her passion for global health and regulatory excellence, Manvi embarked on a transformative journey with the World Health Organization (WHO) in Geneva, Switzerland. As a External Strategic Regulatory Consultant, she led initiatives aimed at strengthening regulatory systems in developing countries. Manvi's strategic guidance was instrumental in developing and implementing key performance indicators (KPIs) for various regulatory functions, fostering collaboration between national regulatory authorities and international stakeholders.
Eager to further expand her impact and leverage her expertise, Manvi transitioned to the corporate sector, joining BioNTech SE in Mainz, Germany, as a Global Regulatory Affairs (RA) Chemistry, Manufacturing, and Controls (CMC) Manager. In this role, she spearheaded regulatory activities throughout the product lifecycle of biological products, with a primary focus on vaccines. Manvi's responsibilities encompassed authoring, reviewing, and approving CMC-related documents, ensuring regulatory compliance for diverse global markets, and providing vital support for the WHO pre-qualification program for vaccines in African nations.
Since 2023, Manvi has been working as a Freelance Strategic Regulatory Consultant, providing tailored regulatory expertise to a diverse clientele. Specializing in strategic regulatory pathways, international compliance requirements, and market access strategies, her consultancy serves as a trusted guide for companies navigating the complex regulatory landscapes governing biological products.