The High Bar for Gene Therapy CMC

White Paper The High Bar for Gene Therapy CMCHow drug developers can step up to meet regulatory expectations for gene therapy chemistry manufacturing and controls. After well publicized stumbling blocks in the late-90s, vigor was restored to the gene therapy field in...

Regulatory Consulting

BioTechLogic’s regulatory consulting team has supported and prepared global regulatory submissions in the eCTD format.

Our experience includes FDA Briefing packages, CTD Module 2 (Quality Overall Summary) and Module 3 (Quality) regulatory submissions.

Our experience includes FDA Briefing packages, CTD Module 2 (Quality Overall Summary) and Module 3 (Quality) regulatory submissions for the following products:

  • Vaccines
  • Recombinant proteins
  • Fusion proteins
  • Monoclonal antibodies
  • Antibody fragments
  • PEGylated products
  • Blood products
  • Oligonucleotides
  • Biosimilars
  • Combination products
  • Small molecules (parenteral products and solid oral dosage)

BioTechLogic has the staff to support the full preparation of Module 2.3 (QOS) and Module 3 (Quality) for global regulatory submission.


BioTechLogics’s regulatory consulting team can:

  • Commercialization and submission readiness gap assessments
  • Review and evaluation of manufacturing data as well as technical evaluations of submission source report
  • Development and review of CMC regulatory filings from Phase I INDs through License Submissions
  • Global regulatory consulting and CMC strategies, planning and project management
  • Preparation and review of regulatory documentation including Briefing Packages, IND, BLA, NDA, IMPD, MAA, Supplements/Variations or ROW filings
  • Preparation of regulatory documentation in the CTD format for Drug Substance, Drug Product and Combination Products (Device and biologic)
  • Preparation and review of US combination product regional requirements including gap assessment’s against FDA requirements and industry practice, device design control matrices, risk assessments and technical expertise
  • Pre-Approval Inspection (PAI)/Pre-Licensing Inspection (PLI) readiness strategies, audits and remediation plans
  • Preparation for FDA meetings relating to End of Phase II meetings, BLA/NDA Meetings, and Facilities or Process Meetings
  • Assistance in responding to regulatory questions from all global regulatory bodies