Leuven, Flemish Region, Belgium
Strand is a consultancy partner for companies in the pharma, biotech and medtech industries. Our services include consultancy, project staffing, project management, service management (outsourcing), training, and permanent recruitment. We provide expertise in quality management, regulatory affairs, research & development, and supply chain management within the pharma, biotech, and medtech industries.
- MAST activities by supporting the transfer of the production process and analytical methods into cGMP manufacturing. - Analytical support for analytical methods transfers within in GsP environment, working close-by with Subject matter experts (SMEs) through close partner collaboration. - Collaboration with USP and DSP team to provide analytical data on process optimization and SDM - Assess the Critical Process Parameters (CPPs) and Critica Quality Attributes (CQAs) at full scale in GsP environment - Establishment of analytical data tracking and trending - Support the Process Lifecycle Management
The QbD Group supports life science companies worldwide throughout the entire product lifecycle – from idea to patient. We are a global company with over 700 high-qualified employees. Our experienced team serves the wider life science industry, with a strong focus on ATMPs, medical devices, IVDs, and digital health, thanks to the specific expertise we have built in these areas.
- Scientific activities by designing and executing SDM for DSP process - Scientific evaluation of generated results by delivering projects within budget, quality, schedule, - Identify and assess problems and risks in the planning - the progress - the quality - the results and agree on solutions with the collaborator - Act as the point of contact and report periodically on the progress of projects and interim project results - ensure a transparent, fluent and effective communication