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 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