Launching your product on the market, and keeping it there
Successfully bringing your product to market is a huge step forward, but often it is only the beginning of it lifecycle.
At Accelagen, we focus on both the short- and long-term goals. Through expert lifecycle management services, we ensure your product getsto and stays on the market by successfully navigating the ongoing regulatory maintenance activities as product changes and improvements are made, or new data comes to light to support possible expansion. Importantly, advances in more efficient manufacturing procedures may require updates and/or modifications to the regulatory status and dossier content.
Staying abreast of your product’s evolving needs requires expert guidance. As your partner, we support you in the full suite of comprehensive post-market product lifecycle management to future-proof your product’s ongoing success.
- 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
How we work
Preparation and lodgement of new submissions
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Continuous critical evaluation of new data to support a variation
Rapid response to regulatory agency questions and post-approval commitment documentation
Updates to product information and labelling
Manufacturing and formulation variations throughout the product lifecycle
Updates to regulatory documentation and product status
Product lifecycle management
case studies
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