Services Medicines Post Licensing

Post Licensing

At DLRC 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, DLRC partners with our clients on all aspects of post-licensing activities.

Post Licensing Activity
Regulatory Compliance
Line Extensions
Post-marketing Variations
Renewals
Transfer of Ownership and Divestment

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). In addition, the majority of regulatory approvals come with commitments that must be met. DLRC 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.

Line Extensions

Line extensions are often a key component of successful life cycle management. DLRC 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. DLRC has extensive experience of submitting variations globally across all types of changes.

Renewals

Periodic renewals of marketing authorisations are required globally. DLRC supports our clients by advising on requirements as well as managing the entire renewal process across multiple markets.

Transfer of Ownership and Divestment

DLRC has extensive experience supporting clients who wish to sell or acquire products globally, ensuring that the marketing authorisations are transferred to the buyer per the agreed timelines and with minimum disruption to ensure a seamless transition in the marketplace. DLRC can also provide support during the public offering, responding to questions in Due Diligence and inputting into the contracts where needed.

Case studies

Take a look at how we have helped some of our clients.

Client 1

Challenge

Client transferring finished product manufacturing and batch release to new site with several manufacturing changes. The client holds the existing drug substance stock. Active supplier is no longer supplying so site re-audit not possible.

Solution

DLRC worked with the QP to mitigate the risks on the existing active substance. DLRC engaged the MHRA to negotiate the site audit requirements and developed a strategy for grouping the variation changes, then established a composite coordination collection submission to reduce the assessment timelines.

Outcome

Variation submission strategy agreed and overall timelines for approval reduced by 5 months allowing for an earlier product launch.

Post Licensing Activity Case Study
Client 2

Challenge

A top 5 global pharma company need fully outsourced regulatory strategic and operational support for a range of development and marketed products.

Solution

For over 5 years, DLRC has provided EU/RoW strategic regulatory support across a portfolio of development projects and marketed products for a Top 5 global pharma company. We have supported over 70 programs during this time with our consultants embedded in the Client’s product development and commercialisation teams.

Outcome

The high quality of our service, consistency in exceeding KPIs and cost-effective resource model has ensured that we have retained and expanded the business over a prolonged period.

Post Licensing Activity Case Study

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