Our Experts

At Medifodil, Candis Edwards brings over 45 years of distinguished pharmaceutical industry experience in Regulatory Affairs, Pharmacovigilance, and Product Lifecycle Management. As our U.S. Strategic Partner, she strengthens Medifodil's capabilities in global regulatory strategy, compliance, and client engagement across the U.S. market.

Her expertise encompasses FDA regulatory strategy, INDs, NDAs, ANDAs, 505(b)(2), ANADAs, CTD/eCTD submissions, bioequivalence, clinical regulatory support, safety reporting, risk management, and post marketing obligations.

Her strategic guidance strengthens Medifodil's commitment to regulatory excellence, patient safety, and high quality submissions, supporting pharmaceutical and biotech clients in advancing products and maintaining compliance with global regulatory standards.

At Medifodil, Dr. Ravi Sekhar Kasibattha brings over 40 years of distinguished experience in Clinical Research & Development, strengthening our ability to deliver world class clinical research solutions.

His expertise encompasses clinical research, bioanalysis, pharmacokinetics, pharmacodynamics, biopharmaceutics, BA/BE studies, IVIVC, biosimilars, and clinical endpoint studies across multiple therapeutic areas, including dermatology, ophthalmology, and respiratory medicine.

His strategic guidance enhances Medifodil's commitment to scientific excellence, regulatory compliance, and the delivery of high quality studies aligned with GCP, GLP, ISO, and global regulatory standards — ensuring reliable and compliant outcomes for our clients.

Dr. Mohanlal Sayana strengthens Medifodil's pharmacovigilance capabilities with over 38 years of global experience in Drug Safety, Clinical Development, Clinical Operations, and Medical Affairs.

His leadership enhances our ability to deliver end to end pharmacovigilance services, proactive risk management, regulatory compliance, and patient safety solutions throughout the product lifecycle.

With extensive expertise in global safety strategies, cross functional leadership, and operational excellence, he helps Medifodil deliver high quality, compliant, and scientifically driven pharmacovigilance solutions that meet the expectations of global pharmaceutical, biotechnology, and healthcare organizations.

Shobha Reddy Chagam brings over 31 years of global regulatory experience in product lifecycle management and worldwide submissions.

Her expertise includes IND, NDA, ANDA, CTD/eCTD submissions, regulatory compliance, and health authority interactions across regulated and emerging markets.

She strengthens Medifodil's regulatory practice with disciplined submission strategy, dossier quality, and lifecycle compliance that accelerate global market access for our clients.

Dr. B. Prabhakar is a distinguished pharmaceutical research professional with over three decades of expertise in Analytical Research, Analytical Method Development, Validation, and Stability Studies.

His extensive experience includes supporting regulatory submissions across US, EU, and ROW markets, with strong knowledge of ICH, USFDA, GMP, and GLP requirements. He has contributed to 100+ ANDA submissions, developed and validated analytical methods, and guided complex quality and regulatory initiatives.

His expertise is further strengthened by significant research contributions, international regulatory audit experience, and multiple granted US patents.

Monalisa Onwuka is a seasoned pharmaceutical professional with over 16 years of global experience in Medical Information Contact Centers (MICC), Pharmacovigilance, Patient Safety, and Medical Affairs.

Her expertise lies in establishing and optimizing compliant, patient centric medical information operations that meet global regulatory standards, with proven experience across Medical Information, REMS, Patient Support Programs, Customer Service, and Product Recall management.

Skilled in building scalable, inspection ready solutions that enhance operational excellence and customer experience, she plays a key role at Medifodil in delivering high quality global Medical Information Contact Center services with scientific accuracy, regulatory compliance, and operational excellence.