Licence Maintenance & LCM

Lifecycle Management

The pharmaceutical industry is evolving and highly competitive. Regulink can assist with the LCM of an existing product or portfolio to help realise the value, for sustaining growth and profitability.

Lifecycle Management (LCM) is the implementation of optimisation strategies to harness the total value of a product during its market journey, from its conception, through development and manufacture, to supply/use and disposal.

Regulink will help develop and promote strategies to prolong a products life by e.g. investigations of reclassification; re-formulation; new forms or presentations (also, finding new delivery devices and packaging solutions); new indications or posologies; more efficient logistics; improved formulations; and improved manufacturing processes aimed at optimising batch sizes, shortening process lead times and making the process more robust; entering new market territories. All such strategies afforded by LCM, assist in gaining a competitive edge in this busy global market.

Post-approval maintenance

We can also assist you in steering through pharmaceutical industry guidance, for example for medicinal products, with variation types and dossier requirements. Such post-marketing activities as these are vital part of a drug product’s lifecycle. Extensive experience and knowledge is available to successfully support any post-licensing maintenance activities.

Contact Regulink for assistance with planning, strategising and implementing your license maintenance obligations as well as product-life extending initiatives.

Regulink regularly helps its pharma clients with:

  • Renewals, Variations, Annual Reports
  • Line Extensions
  • Reclassifications – see case study
  • Geo-expansion projects – see case study
  • Product Information updates
  • New packaging and delivery systems
  • CMC improvements
  • Clinical updates

Case Studies

Regulink has hands on experience of all of these essential post-approval maintenance and ‘ever-greening’ activities for your Marketing Authorisations.

Please refer to our case studies where a focus is provided on specific relevant projects associated with an (EU) market expansion for a client’s key product, as well as successful reclassification (“switch”) applications in the UK market.

OTHER REGULATORY AFFAIRS SERVICES

Whether it be a special regulatory project, intelligence, strategy or support with the essential life cycle management aspects, Regulink provides solutions that have delivered successful and cost-effective outcomes time after time. We are proud of the range and quality of services that we can provide, evidenced by the long term working partnerships we have established with our varied client list.