TECH TRANSFER & PROJECT MANAGEMENT
A technology transfer is what happens when a pharmaceutical company wants to change from an existing manufacturing site to a new manufacturing site. MEDVACON helps our clients by providing senior level pharmaceutical technology transfer experts to lead each technology transfer project. These projects are multi-year in duration and that is why it is critical to have onsite support for the duration of the project.
Tech Transfer Consulting: Laboratory,
Manufacturing and CMO
MEDVACON was engaged in a multifaceted compliance consulting initiative. Client had just completed Phase III Clinical Trials for a drug that addresses unmet medical needs in hyperkinetic movement disorders and engaged MEDVACON for overall compliance assistance with commercialization of the product. MEDVACON provided compliance expertise to the client and their Contract Manufacturing Organization (CMO) with specific focus in the area of process validation, Equipment Qualification, Cleaning Validation, Tech-Transfer, Laboratory instrument qualification, and overall compliance assistance.
cGMP & Quality Audit - API Supplier, Contract Laboratory & API Storage Warehouse
MEDVACON was engaged by a market leader in transdermal therapeutic systems (TTS) and oral thin films (OTF) to provide assistance with Tech Transfer. Client enlisted MEDVACON to provide consulting services specifically in the area of analyzing data and acceptance criteria associated with the technical transfer of their TTS for treatment of Parkinson's disease and moderate-to-severe primary restless leg syndrome into the clients NJ manufacturing site.
CSV & cGMP Audit of Hosting
MEDVACON was engaged by a pharmaceutical company to provide senior level program and project management for a multi-year tech transfer for a key product involving international coordination. MEDVACON's Sr. Project Manager performed a Gap Analysis, Developed a Quality Plan, Provided Validation Master Plan Support, Refined and Manages a detailed Program Schedule Gantt Chart, Refined and Manages a Resource Plan with RACI Matrix and conducted Risk Analysis and Mitigation Planning in addition to providing overarching Project Management.