Regulatory
BioTechLogic has experience in the preparation of the following regulatory submission documentation:
- New Drug Applications (NDAs)
- Biologic License Applications (BLAs)
- Marketing Authorization Applications (MAAs)
- Premarket Approval Application (PMA) – Combination Products
- Briefing Packages
- Responses to Regulatory Agency Questions and Inquiries
BioTechLogic has prepared regulatory documentation in the Common Technical Document (CTD) format for the following compounds:
Proteins:
- Cytokine, Recombinant Protein
- Tissue Factor, Recombinant Protein
- PEGylated Antibody Fragment
- PEGylated Growth Hormone Antagonist, Recombinant Protein
- Monoclonal Antibody
- Growth Factor, Recombinant Protein
Oligonucleotides:
- PEGylated Oligonucleotide
- Synthetic RNA
Blood Products:
- Blood-Based Protein
Combination Products:
- Biologic-device
BioTechLogic's team has prepared Chemistry, Manufacturing, and Controls (CMC) documentation as well as Quality Overall Summaries (QOS) in the CTD Format that have been submitted globally. We have a complete and experienced team to prepare Module 2 (QOS) and Module 3 (CMC) of the CTD.
Our team's expertise in Genetics, Cell Banking, Protein, Blood Products and Oligonucleotide Technology, Drug Substance and Drug Product development and manufacturing, facilities and BioAnalytical methodology provides the essential core knowledge needed to prepare a complete, harmonized CMC submission. The table below provides an overview of our recent regulatory experience.
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 |