Being a player in the pharmaceuticals/chemical industries and very likely the owner the process from idea through R&D to sales, you probably know that there are many pitfalls in obtaining marketing authorisations and selling your scientific research as commercial products on your diverse export markets.
It applies to drugs for human administration, but also to drugs for veterinary use, various medical devices and to products used in cosmetics. Medicare and other products that affect the environment and those who live in it, like agricultural and horticultural chemicals, are also examples of products that are subject to severe restrictions and require marketing authorisations and approval of marketing strategies by local public-health authorities.
Your success with Marketing and Regulatory activities and ensuing commercialisation on research depends on careful preparation.
Development of eg a new drug takes many years, and only very few drugs make it to the market and give you your well-earned return on investment. However, those that do are subject to strict requirements to product labelling and marketing strategies. Often your product packaging and advertising campaign must be approved by public health authorities before launch to ensure that the public is correctly and objectively informed about the drug.
All products subject to market authorisations need to be safe, of a certain standard, quality and efficacy, and compliance with local regulatory requirements is essential to ensure your market presence. To be on top of this, it is key to log your research in a structured and communicable manner for instance by carefully entering, from the very onset of your experiments, your research in laboratory books. This will enable you to document your research later on in your drug approval and marketing authorisation processes, but it will also benefit any IP you may wish to obtain on your research.
The whole process of turning your scientific findings into marketable products and enabling you to monetise on your research revolves around IP. The IP rights that cover your invention and give you the right to commercialise your product need to be designed to fit the diverse requirements of various countries. A drug that can easily be approved in one market may encounter difficulties in other markets – so it is basically a question of having the right IP-rights in the right market. Therefore your regulatory strategy should be incorporated into your IP strategy and be taken into consideration during the entire IP-generating process.
Zacco has the people who can help you find your way around local legislation and practices. We keep track of relevant local regulatory and IP laws and help you through the legal, strategic and scientific issues that affect your business – from idea to product. In this way Zacco applies the IP perspective to help you succeed with your commercialisation efforts.