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:
- Recombinant proteins
- Fusion proteins
- Monoclonal antibodies
- Antibody fragments
- PEGylated products
- Blood products
- 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