Amylaza Consulting provides CMC Regulatory Affairs support including CMC Strategy, authorship and review of CMC sections of INDs, NDAs, BLAs, MAAs and is experienced with FDA and international submissions.
Our approach to regulatory and technical writing is to employ scientists and engineers to generate content. There is a discernible difference in the quality of text prepared by scientists and engineers with impeccable written communication skills compared to that generated by writers learning the science. Amylaza relies on technical subject matter experts to write documents. Our team is quick to learn the subtleties of our client’s processes, and to capture key details in regulatory submissions and supporting reports.
Let Amylaza write for teams that are fully engaged with discovery, development, or manufacturing activities.
Amylaza Consulting frequently writes
- CMC sections of INDs, NDAs, BLAs, and IMPDs
- Technology Transfer Plans / Reports
- Process Descriptions
- Process Development History Reports
- Validation Master Plans
- Process Validation Protocols
- Product Critical Quality Attributes
- Critical Process Parameter Risk Assessments
- Raw Material Risk Assessments
- Change Controls
- Manufacturing Facility Assessments
- Manufacturing Investigations
- Process and Product Related Impurity Assessments
It is our belief that documentation is an important way technical operations teams add value to a developing product. Partners in-licensing a drug will find strong documentation to be an asset during due-diligence, and as programs integrate into their systems. Unfortunately, documentation is often de-prioritized by project teams busy driving their programs forward. As reports linger on the to-do list, some valuable information may be lost.
Let us know how we may contribute to your success.