Global Regulatory CMC Strategy for Biologics: FAQ.

A three-day, expert-led live online workshop on building a global regulatory CMC strategy for biologics: from phase-appropriate development and a submission-ready CMC package to global registration, lifecycle management and the shift to structured data, Digital CMC and AI-enabled regulatory work.

Friday 20 to Sunday 22 November 2026, live online. Day 1: 6:15 PM to 10:00 PM IST (1:45 PM to 5:30 PM CET, 7:45 AM to 11:30 AM ET). Days 2 and 3: 5:00 PM to 10:00 PM IST (12:30 PM to 5:30 PM CET, 6:30 AM to 11:30 AM ET). That is three live sessions and 13 hours 45 minutes in total.

Day 1, Building the Regulatory CMC Strategy: US, EU and global frameworks, phase-appropriate CMC development, QTPP, CQAs, CPPs and control strategy. Day 2, From Development Science to a Submission-Ready CMC Package: cell line and cell banks, upstream and downstream, formulation, characterisation, analytical strategy, specifications, stability, impurities, comparability and process validation. Day 3, Global Registration, Lifecycle Strategy and Digital CMC: country-specific registration, health-authority questions, CMC commitments, post-approval changes, structured regulatory data, Digital CMC, automation, AI and data governance.

It is the plan for how chemistry, manufacturing and controls (CMC) information for a biological product is developed, justified and presented to health authorities across development, registration and the product lifecycle. It links the science of the product and process to what regulators expect in each market and phase.

Professionals in regulatory CMC, global regulatory affairs, biologics and pharmaceutical development, manufacturing and technical operations, quality, analytical development, regulatory operations, and regulatory data and digital transformation. Combination product professionals are included where relevant.

Build a structured, phase-appropriate regulatory CMC strategy for biologics; connect development science with regulatory expectations; recognise US, EU and global registration considerations; evaluate CMC risks in manufacturing, analytics, stability and comparability; think strategically about health-authority interactions and lifecycle changes; and understand how structured data, Digital CMC, automation and AI are changing regulatory CMC.

Neha Parashar, RAC, PMP, Founder and CEO of RegAtrium, with 13+ years of global regulatory experience in CMC strategy for biologics and combination products, global submissions and health-authority interactions. She was formerly Director, CMC Regulatory and Devices at argenx Germany.

Live online, with expert-led sessions, practical case discussions, interactive Q&A and a real-world regulatory perspective.

Yes. Every participant receives complimentary access to our self-paced course Biologics CMC Fundamentals: Development to Regulatory Filing (value USD 99, or INR 6,999 in India) as pre-reading. It is not mandatory, but it is highly recommended if you are new to biologics or want to refresh the fundamentals. You can also earn its certificate of completion and digital badge.

India: INR 29,500 (INR 25,000 + 18% GST). Europe: EUR 500. USA and other countries: USD 550.

Yes. Participants who complete the workshop receive a RegAtrium Certificate of Completion with a credential ID that can be checked on the certificate verification page.

Register on the workshop page. For questions, email info@regatrium.com or call +91 96851 00662.