Services

Provide consultancy services within the areas of parenteral drug products and drug-device combination products, Medical Devices, aseptic processes including formulation, filtration, filling, and lyophilization.

Current assignments include:

• Medical device and combination products, focusing on Design Control and regulatory submission readiness.
• Strategic alignment and remediation of diverse combination product design history files, thereby enhancing compliance and facilitating life cycle management activities.
• Medical device development: innovate a new medical device and produce working prototypes for further testing.
• Biopharmaceutical drug manufacturing: Production support through operational excellence and continuous improvements, and production issue investigations.