Product Commercialisation > In Licensing / Out Licensing

In Licensing / Out Licensing

In Licensing / Out Licensing

In addition to our core regulatory business, we also offer our clients an In/Out licencing service for Rx (generic & branded) and OTC products.

This has been a natural extension to CambReg’s business as after 20 years of trading we are in the privileged position of having a large number of contacts, across the pharmaceutical industry,  in all major markets. 

We have helped clients in this area for more than 5 years now and have brokered deals worth several million pounds.

This area of our business is flourishing as with each deal concluded more contacts in the business development arena are made.  We are keen to partner with more companies offering full-scale product development and/or manufacturing services so please give us a call on 0044 (0)1480 465755 to discuss how a relationship with CambReg can benefit you.

In licensing

If you are looking for a product and do not have the experience to handle these types of activities, we are the company for you.

Product Development with Dossier Purchase

We offer a fully project-managed service for these activities whether it’s for a generic or line extension. We maintain a list of all current Marketing Authorisation holders in the UK (going back 20 years). This is a good starting point for analysing your competitors for the product of interest. Working in tandem with our Marketing Partner, Derek Gallacher of CamMia (link to his web site or email ) Consulting, we can tell you if it’s a project that is worthwhile pursuing, helping you with an ROI plan. Once this has been established we can to first explore the possibilities of Own Label Supply, MA acquisition or Duplicate Application (see below) from current MA holders or approach the appropriate development company.   

Please contact our CEO Dr Pallav Shah who specialises in this area.

CambReg gets you from Concept to Market

Duplicate Application

One way of the quickest routes to market is to obtain a duplicate MA. In the UK the process is referred to as a ‘Piggyback Application’  and is a very efficient one, getting you an MA in around 3 months from application. If you feel you have got the right set up in terms of reach and distribution then we can find you MAs to duplicate. Many of our existing clients are interested in doing such deals.

Time to receive an MA in other EU member states can also be as short as 3 months but this does depend on which member states are involved as some take longer. Time to market depends on who is going to supply the product.  If it is the original MA holder this can be as soon as 3 to 4 months from signature of the agreement.

There is a very specific duplication scenario that may appeal to you if you have a presence outside the EU and don’t want to market in the EU.  We are happy to share this information with you   

Change of Ownership

We have clients with very large portfolios of products who are often looking to divest their assets; including not only generics but OTCs and tired old innovator products that need new life breathed into them.  If this route to market appeals to you please give us a call
Time to market can be approximately 6 months from the signature of the agreement but this will depend on whether or not there is to be a change of manufacturing site

Own Label Supply (OLS)

In the UK there is special provision to add an ‘Own label’ supplier to an existing MA.  We recently researched all major EU markets and found no evidence that this option exists outside the UK.  It is an excellent way to get started if you want to supply medicines without the costs and responsibilities that come with owning your own MA

Time to market is approximately 6 months from the signature of the agreement.  Only a Type IB variation is required

Out licensing

if you are an MA holder wishing to divest products, a manufacturer or a product development company we would like to hear from you as we have many clients who are seeking MAs/Dossiers both new and old.

For more information or an estimate, contact us »

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