Navigating the CMC pathway for biosimilars requires strategic planning, scientific excellence, and deep regulatory expertise. At Asphalion, we support our partners throughout the entire product lifecycle — from early development to post-approval activities.
Our CMC services for biosimilars include:
Early & Clinical Development
• CMC regulatory strategy tailored to US, EU, Canada, & Australia
• Reference medicinal product selection
• QbD implementation & QTPP definition
• Manufacturing process characterisation, scale-up & validation
• Analytical method development, validation & transfer
• Similarity and comparability studies
• Stability strategy & shelf-life determination
Marketing Authorisation
• Module 2.3 & Module 3 (eCTD) authoring (IMPDs, INDs, MAAs, BLAs)
• GMP compliance support
• Responses to Regulatory Authorities
Post-Approval & Lifecycle Management
• CMC change control
• Post-approval changes management
• Analytical comparability exercises
• Regulatory strategy for post-approval changes
In addition, we provide gap analysis, due diligence, scientific advice support, project management, and tailored training workshops on biosimilar CMC regulatory topics.
Whether you are starting your biosimilar journey or managing complex post-approval changes, Asphalion can guide you every step of the way.
Have a look at the document to discover the full range of solutions we offer and how we can support your biosimilar journey.
Let’s talk about how we can support your next biosimilar milestone. Contact us! [email protected]
