Regulatory Affairs, GMP & CMC

Regulatory Affairs, GMP and CMC

  • Routes to local regulatory approval in key Asian markets such as PMDA (Japan), MFDS (South Korea), NMPA (P.R. China), HA (Hong Kong S.A.R.), FDA (Taiwan), HSA (Singapore) and FDA (Thailand).
  • Help with writing URS and review of facility design, specifications, layout, and engineering in compliance with US FDA, EMA, PIC/S, or WHO cGMP.
  • GMP review of biopharma (including Cell & Gene Therapies), pharmaceutical. vaccines and med tech. 
  • Mock GMP audits and gap-analysis.
  • Advice and recommendations for Bioprocess Development both up- and downstream.

ADB Life sciences also has resources and necessary skillsets to support Production, what is commonly called CMC – “Chemistry, Manufacturing, and Controls” in particular in biologics (innovative biopharma, biosimilars, vaccines, cell and gene therapies), covering all steps in bioprocess development and scale-up, including de-bottlenecking and scale-down for biosafety testing. We have both in-house and net-work partners having upstream and downstream expertise with proven technology and cutting-edge know-how, to achieve regulatory fast track for your products under development. Through our partnerships, 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. We also provides project coordination & management.