Capital and New Product Project Management
Capital and Project Management
From beginning to end, expert project management is crucial to bringing your new pharmaceutical product to market, or the success of a new capital project.
Galenisys can provide highly qualified project managers with decades of management experience within the pharmaceutical industry, expertise in engineering and regulatory interaction, and most importantly – quality and compliance.
Whether you are building a new facility, installing new production lines or embarking on a new product project, we will provide up-to-date technical, quality and compliance expertise to ensure it runs smoothly, on time and meets regulatory requirements.
Galenisys will manage your project through its entire lifecycle – helping ensure a smooth regulatory registration process upon completion.
Quality, compliance and engineering aspects of design
Galenisys will ensure your facilities, equipment and utilities meet the right quality, compliance, engineering and design requirements, including:
- Design specifications
- Purchasing specifications and supplier selection
- Personnel and material flows (when relevant)
- Contamination control
- Controlled environment provisions and access control
Complete pharmaceutical project management
To help ensure the success of your project, our pharmaceutical project managers will also undertake the following:
Beginning to end project management:
- Project audit and decision trails
- Project stages and approval points
- CMC and BLA preparation
- Commissioning, qualification and validation of facilities, equipment, utilities and processes, including protocols and final reports
- The smooth implementation of the project into routine manufacturing and control
Management of regulatory inspection and approval:
- Preparation and training for pre-approval inspections
- Interaction with regulatory authorities
- Management of pre-approval inspections
- Inspection follow-up and corrective actions
Our project managers will oversee every aspect of your project down to the last detail, including producing effective project documentation to ensure the smooth transition of the project from its development phase into routine operations.