Post Approval/
Post Licensing
We understand the importance of life cycle management to a product’s success.
From compliance activities to detailed strategies for line extensions and new indications.
Regulatory Compliance
- Once a product is approved, information continues to be provided to the regulators through requirements such as Periodic Benefit Risk Evaluation Reports (PBRERs)/Periodic Safety Update Reports (PSURs).
- We have extensive experience of post-marketing regulatory requirements and can help guide you on what is needed and when to keep your product on the market.
- In addition, the majority of regulatory approvals come with commitments that must be met
Line Extensions
Line extensions are often a key component of successful life cycle management.
We can support these activities with strategic advice and advice on regulatory requirements through fully managing the documentation and procedure.
Post-marketing Variations
From minor administrative updates to new clinical indications and manufacturing changes, variations to approved products are of paramount importance throughout the product life cycle.
We have extensive experience of submitting variations globally across all types of changes.
Renewals
Periodic renewals of marketing authorisations are required globally. We support our clients by advising on requirements as well as managing the entire renewal process across multiple markets.
Transfer of Ownership and Divestment
We have extensive experience in supporting clients who wish to sell or acquire products globally, ensuring that the marketing authorizations are transferred to the buyer per the agreed timelines and with minimum disruption to ensure a seamless transition in the marketplace.
We can also provide support during the public offering, responding to questions in due diligence and inputting into the contracts where needed.
