MFPL’s regulatory support and oversight provides a strong foundation for a successful clinical program. MFPL’s team hold a leadership position in the Scientific and Clinical Regulatory Affairs with strong experience, knowledge and reliability.
We have the expertise to provide expert clinical and regulatory support through all phases of global drug development to commercialization, from BA/BE Analysis to Quality cGMP compliance. We prepare all regulatory documentation including filing of DMFs, ANDAs and maintaining post approval change management. Our proficiency in organizing quality dossiers ensures timely approvals.
Our company has experience of dealing with leading authorities, across data management, regulatory affairs and biostatistics which has helped our clients completing regulatory activities across USA, EU, Asia Pacific and Latin America.
We understand our client’s needs and analyze their regulatory needs. With advance planning and strong and stringent execution of regulatory filings in compliance with respective regulatory agencies, we provide global current regulatory support to our clients ahead of the time.