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Marketing and Regulatory

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.

Marketing

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.

Regulatory

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.

IP

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.

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Hampus Adlerton

Hampus Adlerton

Senior Partner
Attorney at Law
Claes Agnvall

Claes Agnvall

Senior PartnerTeam Manager
Attorney at LawEuropean Trademark and Design Attorney
Judith Albers

Judith Albers

Attorney at Law
Kristin Kjærheim  Astrup

Kristin Kjærheim Astrup

Senior PartnerManaging Director, Innovation Technology Norway
Attorney at Law
Maria Beijer

Maria Beijer

Senior Partner
Attorney at Law
Marcus Eilenberg

Marcus Eilenberg

Partner
Attorney at Law
Stig Ekmann

Stig H. Ekmann

Partner
Attorney at Law
Kristian Elftorp

Kristian Elftorp

Associate Attorney
Attorney at Law
Peter Eriksson

Peter Eriksson

Partner
Attorney at LawEuropean Trademark and Design Attorney
Anders Feldt

Anders Feldt

Senior Partner
Attorney at Law
Gunilla Hedenquist

Gunilla Hedenquist

Associate Attorney
Attorney at Law
Margaretha Fjällström  Holmberg

Margaretha Fjällström Holmberg

Partner IP Advisory Administration
Magdalena Jerner

Magdalena Jerner

Senior Partner
Attorney at LawEuropean Trademark and Design Attorney
Nils Köster

Nils Köster

Partner
Attorney at Law
Frode André  Moen

Frode André Moen

Partner
Attorney at Law
Thomas Mølsgaard

Thomas Mølsgaard

PartnerManager Trademark and Legal, Denmark & Sweden South
Attorney at LawEuropean Trademark and Design Attorney
Ane Strand  Nilssen

Ane Strand Nilssen

Associate lawyer
Dag Petré

Dag Petré

PartnerPatent Attorney
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