In- & Out-Licensing
Marketing and increasing sales through licensing, developments, and acquisitions of medical products
Pharma Expertise Consulting advises you on the further development of your portfolio strategy. We support you with existing medical device approvals, acquisition and granting of licenses and distribution rights, acquisition of new medical devices, and partnered developments in the healthcare sector and the pharmaceutical industry. We are also happy to support you in the development of innovative medical products.
An expansion of the medical product portfolio is possible specifically through an internationalization of distribution rights. You can distribute your German medical device approvals abroad (out-licensing of medical devices)as well as trade foreign medical device approvals in your home market (in-licensing of medical devices). Depending on the target market, there are different legislations here. For example, if you want to market your medical devices in India, you must apply for market access with the Indian regulatory authority for pharmaceuticals, the Central Drugs Standard Control Organization (CDSCO). The CDSCO is responsible for licensing on the part of the central government through the Central Licensing Authority (CLA) and on the part of the states through the State Licensing Authority (SLA). It is responsible for the licensing of import, manufacturing, distribution, inventory, exhibition, and marketing. TÜV SÜD South Asia has been approved by the CDSCO as a Notified Body for the Indian medical device regulation (Medical Device Rules 2017), and is thus authorized to conduct manufacturer audits in accordance with the requirements of this regulation.
For regulated medical devices that are already approved in the European Union, USA, Canada, Japan or Australia and are to be imported into India, an abbreviated conformity assessment procedure can be requested for legitimate distribution.
Another option for the medical device manufacturer (original equipment manufacturer) is to grant distribution rights to other domestic distributors. Here, the private label manufacturer (PLM) system is key. A PLM is a company that serves as a manufacturer within the scope of medical device law and obtains a CE mark but does not produce the products itself. The PLM does not modify the products or does so only insignificantly; as a rule, it procures, stores, and distributes them under its own name (packaging, brand, etc.).
The Medical Device Regulation (MDR) has made Own-Brand Labeling (OBL) very difficult. Virtual manufacturing is an alternative (MHRA guidance document “Virtual Manufacturing” replaces “Own-Brand Labeling for medical device manufacturers” from March 2017).
We will also be happy to investigate the possibility of third-party sourcing for you. If you would like to expand your portfolio with a specific indication or active ingredient, we will research nationally or internationally which approvals and products are on the market or in development and in which framework they can be sourced (purchase, license acquisition, co-distribution, etc.).
In addition to medical and regulatory tasks, we are also happy to take on the entire project management: from awarding the formulation development contract to conducting the clinical evaluation, identifying suitable contract manufacturers, the approval strategy, preparing the technical documentation,selecting the Notified Body, the approval, CE marking, conformity procedures, and the market launch.
We help you to strengthen your market position by expanding your product portfolio. Feel free to contact us!