Pharmaceutical Co-crystals: Evolving Global Regulatory Perspectives.
Webinar
Pharmaceutical co‑crystals enhance drug solubility, stability, and bioavailability without altering the API. They are multi‑component crystalline solids held together by non‑ionic, non‑covalent interactions. Regulators require structural evidence and proof that the co‑crystal dissociates before pharmacological action. Global pathways for registering co‑crystal‑based products remain unharmonized, making early engagement with authorities essential for correct classification and a sound submission strategy.
Join our regulatory expert in this insider session to explore regulatory perspectives for co-crystals. We will provide overview of major jurisdictions, and provide practical insights into submission preparation.
In this insider session, you will learn:
- What pharmaceutical co-crystals are and their regulatory definition
- The evidence required for co-crystal submission
- Regulatory perspectives on co-crystals by the US, EU, China, India, and Brazil authorities.
Speakers
Dr. Anita Nair
Merck
Head of Regulatory Management- Pharma, Food Materials & Medical Devices
Dr. Anita Nair leads global Regulatory Management for Pharma, Food Materials & Medical Devices within our company, overseeing global registrations and lifecycle management for APIs, excipients, cell culture media, food materials, and medical devices. She also drives Regulatory Intelligence, advocacy, customer support, training, and consultancy to support the Life Science business.
A pharmacist by training, Dr. Nair holds a PhD in Pharmaceutical Technology from Goethe University Frankfurt, where her research focused on the biowaiver concept aligned to US-FDA, EMA, and WHO guidance, resulting in multiple published monographs. She has contributed extensively to dossier preparation for API and excipient registrations, including a strong focus on China regulations. Prior to joining the regulatory team, she served as Head of Laboratory for solubility and physico-chemical characterization of new chemical entities, supporting Healthcare sector. Dr. Nair is co-editor of the book Solubility in Pharmaceutical Chemistry, published in 2020 and serves as a reviewer for international journals including EJPS and the Journal of Pharmaceutical Sciences.
Pharma and biopharma manufacturing
- Solid Formulation Strategies
Duration:47min
Language:English
Session 1:presented June 16, 2026