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

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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