niche
Cell-Gene-Therapy
Where it's used
Biospecimen logistics for clinical trials
Temperature-controlled, chain-of-custody transport and storage of patient-derived samples between trial sites, central labs, and biorepositories.
CMC regulatory consulting (BLA/MAA)
Specialized strategic advisory services guiding biopharma through the complex Chemistry, Manufacturing, and Controls (CMC) requirements to successfully file Biologics License Applications (BLA) and Marketing Authorisation Applications (MAA).