CMC, GMP & Regulatory

• Routes to local regulatory approval in key Asian markets such as PMDA (Japan), MFDS (South Korea), CFDA (P.R. China), HA (Hong Kong S.A.R.), FDA (Taiwan), HSA (Singapore) and FDA (Thailand).
• Review of facility design, specifications, layout, and engineering in compliance with USFDA, EMA, PIC/S, or WHO cGMP.
• GMP review of biopharma (including cell therapies), pharma and med tech. 
• Mock GMP audits and gap-analysis.

ADB Life sciences also has resources and necessary skillsets to support what is commonly called CMC - "Chemistry, Manufacturing, and Controls" in particular in biologics (innovative biopharma, biosimilars, biobetters, vaccines, cell and gene therapies), covering all steps in bioprocess development and scale-up, including de-bottlenecking and scale-down for biosafety testing. ADB Life Sciences has upstream and downstream expertise with proven technology and cutting-edge know-how, to achieve regulatory fast track for client’s products. Through ABD Life Sciences' networks, we can provide experts/consultants for implementation of single-use and disposable technologies, as well fill and finish (release, labelling & packaging), sterile filling (vials, 1 or 2 chamber syringes), tableting, capsules, creams and powders. ADB Life Sciences also provides project coordination & management.