Regulatory Submissions
BioTechLogic's regulatory team has supported global regulatory submission preparations that have included recombinant proteins, antibody fragments, oligonucleotides, monoclonal antibodies, and blood-based proteins. Our team has prepared FDA Briefing packages, Module 2 (Quality Overall Summary) and Module 3 (CMC) CTD regulatory submissions.
Regulatory Submissions Prepared for various types of Molecules:
| Molecule Type | CMC Support (CTD format) |
|---|---|
| Cytokine, Recombinant Protein | Genetics, Cell Bank, Drug Substance, Drug Product |
| Tissue Factor, Recombinant Protein | Genetics, Cell Bank, Drug Substance |
| PEGylated Antibody Fragment | Genetics, Cell Bank, Drug Substance, Drug Product |
| PEGylated Growth Hormone Antagonist, Recombinant Protein | Genetics, Cell Bank, Drug Substance, Drug Product |
| PEGylated Oligonucleotide, synthetic RNA | Drug Substance, Drug Product |
| Monoclonal Antibody | Drug Product |
| Growth Factor, Recombinant Protein | Drug Substance |
| Blood-based Protein | Drug Substance, Drug Product, Analytical |
Examples of Our Regulatory Submission Services:
BioTechLogic will provide regulatory strategies related to the following:
- Development of CMC registration strategies for successful FDA, EMEA, and ROW submission and approval
- 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
BioTechLogic has the staff to support the full preparation of Module 2 (QOS) and Module 3 (CMC) for Global Regulatory Submission. In addition, BioTechLogic will augment a client's staff by performing the following tasks:
- Review and evaluation of manufacturing data
- Development and review of CMC regulatory filings from Phase I INDs through License Submissions
- Preparation of BLA, NDA and MAA regulatory submission documentation in the CTD format for both Drug Substance, Drug Product and Combination Products (Device and biologic)