How Advanced Biologics Consulting can support you

Advanced Biologics Consulting offers flexible working arrangements from fixed scopes of work, with clearly defined deliverables and timelines, through to adhoc support as and when is needed either remotely or on site. 


Activities that can be performed include, but may not be limited to:

Regulatory affairs 

  • Gap analysis of module 3/IND/CTA relative to development stage of product 
  • Authoring of module 2 & 3 (CTA/IND or MAA/BLA) 
  • Scientific advice briefing package review/authoring, including support at scientific advice F2F meetings if needed. 
  • Regulatory strategy for process changes pre- and post-approval 

Product / process development 

  • Process development and product characterisation strategy throughout clinical development and through to commercialisation 
  • Clinical and commercial supply strategies  
  • Scale-up/scale out strategies 
  • CDMO selection and tech transfer activities 
  • Product comparability evaluations 
  • Process qualification / validation strategies 
  • Stability study designs 
  • Specification setting 

Analytical assay development 

  • Assay development / qualification / validation strategies 

CMC due diligence for potential M&A