Chemistry, Manufacturing & Controls

Chemistry Manufacturing & Controls (CMC)

The Peritus team offers technical, strategic regulatory and development support services in CMC.

The CMC team has significant industry experience with biologics (recombinant proteins, monoclonal antibodies, vaccines (both therapeutic and prophylactic), biosimilars, ATMPs (cell, gene and tissue therapies) and small molecules.

The depth of expertise and experience within the CMC team enables Peritus to provide bespoke and often innovative approaches to overcome complex issues encountered in product development and challenging of the status quo.

Examples of recent projects:

• Provision of regulatory CMC support for an oncology gene therapy product and various monoclonal antibodies
• Scientific meetings with FDA / EMEA
• MAA preparation for monoclonal antibody products and vaccines (EMA/FDA)
• Orphan biologic (breakthrough therapy); providing early phase regulatory support for scientific advice meetings and IND/IMPD writing
• Post approval lifecycle regulatory support for vaccines and monoclonal antibodies – including site transfers
• Regulatory strategy and TSE risk assessment for a cancer vaccine in early development
• Set strategy for novel product packaging redesign and subsequent over label

Please call us to see if we can help with your product development CMC requirements.