Services
Common Projects for Amylaza
Development
Take Your Therapy From Concept to Product
CDMO Search and Management
Matching with the Right partner
Regulatory Strategy and Filings
Tell Your Story Clearly
Amylaza Consulting recommends clients take an efficient, phase appropriate, approach to process development by first establishing an appropriate manufacturing process, and subsequently refining and optimizing this process ensure consistency and cost efficacy. We keep the big picture goals in mind, while working with clients to address near term technical concerns. Development efforts must provide adequate design space information for regulatory filings and to de-risk cGMP manufacturing and process validation. Our approach focuses on: Identifying Critical Quality Attributes (CQAs) by risk assessment, or testing Establishing appropriate and scalable manufacturing processes Evaluating Critical Process Parameters (CPPs) by risk assessment, and testing Defining a control strategy to ensure consistent process performance and drug substance quality
Amylaza Consulting helps clients from RFP to PV and beyond. We have extensive contacts at CMOs/CDMOs and an exhaustive database of companies active in the space to aid in a site selection. We are experienced transferring processes from lab to CMO, and from CMO to CMO. We will serve as the sponsor’s representative to manage the project and relationship with the CMO, or as advisors to a team on one side of the tech transfer. ​ As search consultants, we’ll help clients draft RFPs, and manage initial contacts with CMOs. We will coordinate joint approval of confidentiality agreements (CDAs) before circulating the RFPs or discussing process or product specifics. Client confidentiality is a priority for us. Amylaza can manage technical discussions and requested clarifications to help potential partners deliver a detailed proposal.  We will summarize the proposals for our clients and suggest the best fits. We advise clients to perform site visits and a full Quality audit before contracting for GMP work. ​ Once a CMO/CDMO has been selected, Amylaza can drive, or support, a program as required by our clients.  We provide the following services for outsourced development and manufacturing: Tech transfer plans Effective kick-off meetings Project management for the sponsor Direction for process development Person-in-plant Technical troubleshooting Validation master plan and protocol authorship or review Batch record review and data trending Pre-approval inspection preparation and on-site support
Amylaza Consulting provides Regulatory Affairs Leadership including CMC Strategy, authorship and review of pIND, 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.