Amylaza is a boutique consulting firm providing services to companies active in the bio pharmaceutical space, and those looking to learn more about the industry. Amylaza provides brief conversations about key topics, resources to manage or direct a project, or a ready made team to design and execute a CMC startegy.
Drug development firms look to us to address technical operations concerns ranging from outsourcing strategy, technology transfer, and specific process development challenges. We understand regulatory expectations, and use phase appropriate expectations of submission content to prioritize development efforts and documentation. Many of our clients value process portability as part of their business development, and risk management strategies.
Amylaza consultants will serve as compliance auditors for our clients.
We provide CMC Regulatory and technical writing support. Services include composition and review of INDs, NDAs, BLAs, IMPDs, etc. Our staff will also author consolidated and polished process descriptions, development, tech transfer, and validation reports suitable for inclusion with a submission.
Architecture and engineering firms partner with us to provide an in-house voice of the client, and advocate for process needs. We recommend process specific equipment, room layout, and classifications to aid in conceptual and detailed design of manufacturing facilities.
Amylaza provides its biopharmaceutical industry expertise to investment banks, material and/or service providers looking to better understand the current state of the industry and emerging trends.
Contact us to learn more.