ASPE Conseil is a regulatory affairs and quality consulting firm and training provider with a team of consultants offering extensive experience of the health product sector. Drawing on 30 years’ experience, our company offers guidance and tools enabling you to meet regulatory and quality requirements encountered at each stage of your products’ life cycles.
Our Expertise on Health Products
Regulatory Affairs & Quality
A wide range of services Adapted To Your Project
Our consultants provide technical and regulatory support to develop the most appropriate development and marketing strategy for your product.
Drafting and Follow-up
In close collaboration with you, we realize the drafting, the submission to the authorities and the follow-up of the file of registration of your product according to the regulatory and normative requirements.
We assist you in setting up and during the certification audit of your Quality Management System according to European and international standards. We audit your SMQ.
We offer training modules on the regulations, standards and guidelines that govern your business, allowing you to apply them and anticipate their changes.
In addition to essential experience of conventional medicine, we offer long-standing expertise in the fields of homeopathy and herbal medicine as well as a proven track record in biotechnology.
Our multidisciplinary team is able to manage class I to III MD projects: active/non-active MDs, implantable MDs, IVD, connected MDs, and MDs combined with medicinal substances.
We can help you adjust to a new regulatory landscape (health claims) with specific expertise on plant-based products.
Our consultants help manufacturers of cosmetic products to implement European Regulation 1223/2009/EC (GMP, PIF, responsible person, safety assessment).
Our Valued Clients