Lifecycle Management

Getting your product or device to market is a significant step, but usually it is only the beginning of the process. Our Lifecycle Management service offering is critical to ensuring your product gets to and stays on the market by expertly navigating the required ongoing regulatory processes as product alterations are made or new data comes to light to support new claims, or more efficient manufacturing steps introduced that require updating and/or modification to the regulatory status and documentation.

Services our experts provide in the post-market product lifecycle:​

• Preparation and lodgement of new submissions
• Response to Agency questions
• Documenting any post-approval commitments agreed with the Regulatory Agency
• Critically evaluating new data intended to support a variation
• Updates to product information and labelling
• Manufacturing and formulation variations throughout the product lifecycle
• Updates to regulatory documentation and product status