Paving the Way for Medicinal Products

Improving EU regulatory environment for pharma company

Our client Heel is a leading manufacturer of homeopathic medicinal products strongly dedicated to scientific research. Heel had to deal with a non-suitable regulatory environment. Existing requirements as applied by competent national authorities did not honor investments in scientific research. Alber & Geiger faced a European Commission not being open for any changes in legislation. Alber & Geiger needed to also address issues on national level and develop a strategy before relevant national competent authorities.

Providing coherent legal arguments

ag-wins-map-healthcareThe strategy co-ordinated legal, ethical, medical and scientific concepts into coherent arguments. It showed the European Commission and the EU institutions but also relevant national competent authorities more broadly, the particularities of homeopathic medicinal products, as well as their effectiveness and safety and the different national approaches in the EU Member States.

Laying the foundations for meaningful dialogue

Trusted EU specialists
Dr. Gunther Herr- Director Regulatory & Legal Affairs, Heel GmbH
Ultimately our strategy allowed our client to enter into a constructive dialogue with relevant national authorities. Alber & Geiger followed the maxim that sometimes less regulation is more. We are always learning the technicalities and nature of our clients’ industries. We take this growing awareness to the forefront of policy and legislation making.