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Guaranteeing efficacy and safety

Guaranteeing efficacy and safety

The main mission of Arkopharma Laboratories is to offer products that are both effective and extremely well tolerated. As a stakeholder in all developments, Scientific Affairs constitutes one of the four specific fields of the R&D department, alongside Formulation, Analytics and Regulatory Affairs.

What is the role of Scientific Affairs?

In the course of its development, each product systematically passes through this sub-department: the scientific team is responsible for determining the scientific rationale behind all the active ingredients that make up the final product.

  • Regarding safety: It assesses the toxicological profile of the product’s active ingredients and the need to state on the packaging any precautions and/or specific contraindications for certain at-risk populations (pregnant or breastfeeding women, children, people suffering from allergies, chronic illnesses, or taking medication), to ensure that consumers and healthcare professionals have access to all the required information.
  • Regarding proof of efficacy: The scientific team makes its assessments on the basis of pharmacological and clinical data from specialized publications, as well as articles published in scientific literature.

Responsibility lies with Scientific Affairs as guarantor of the efficacy and safety of the products marketed by the Arkopharma Group.

Backed up by knowledge and scientific studies

For certain products, the department also conducts pharmacological or clinical studies or usage trials in order to assess the mechanism of action, efficacy and level of customer satisfaction.

These studies are carried out in partnership with CROs (Contract Research Organizations), academic laboratories or hospitals.

As an example, the dietary supplement Phyto soya designed to alleviate the hot flashes associated with the menopause was subjected to two efficacy studies and a safety trial, all of which were published in globally-renowned scientific journals.

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Along with experts from Research & Development and the Formulation department, Scientific Affairs is also part of the Innovation group set up by the laboratories.

What’s the mission of the group? To organize scientific brainstorming sessions, share and compare sources, explore a range of potential studies and come up with innovative ideas.