Bioglan Services

Life cycle management The close partnership with our customers also involves support during the entire product life cycle. • Proactive communication regarding product improvements • Timely communication of changes to support maintenance of the product dossier • Using annual PQR as a source of continuous improvement of the product • Support in risk assessments according to regulations • Safety data exchange support Tech transfer service The experienced team of project managers support you in the tech transfer process and have extensive understanding of the commercial manufacturing processes. We use a risk-based approach and well established project practices. Transparency through the project and frequent status reporting will assure you are involved in the project and decision process. Tech transfer core activities: • GAP analysis sending vs receiving unit • Risk assessment • Analytical method transfer and verification/validation • Sourcing and supplier qualification including audit services • Process optimization including technical batches • Cleaning validation • Process validation • Manufacturing of stability batches • Stability studies (ICH) • Regulatory support