Project Manager and Business Development Specialist providing consultancy and lyophilization services to projects involving the qualification of existing and new pharmaceutical equipment and the validation of processes falling under the GMP & FDA regulations for the pharmaceutical and biotechnology sectors. Expertise in bringing a comprehensive market perspective, ensuring seamless project management and impactful results within these industries.Through ASEPTIC ACADEMY, we also offer consultancy services on topics related to pharmaceutical manufacturing in an aseptic environment to cover the “GAP” between process requirements and professional skills.HOW CAN WE HELP YOU? 🔬LYOPHILIZED NEW PRODUCTS AND PROCESS DEVELOPMENT:• Formulation development.• Product characterisation & analysis• Process development (Design space approach) & optimization• Technology transfer & Scale-up.• Small non-GMP batches.• GMP batches (partners) ✍️NEW MANUFACTURING FACILITIES, UTILITIES & EQUIPMENT (GMP COMPLIANCE SERVICES):• Validation Master Plan• Plant Design & Qualification• Facilities & Utilities Qualification• Process Equipment Qualification• Quality Management Systems 💊NEW MANUFACTURING PROCESSES:• Process Validation.• GMP Audits.• Equipment requalification.• Process Revalidation.• Personnel qualification --> ASEPTIC ACADEMY.