Notre Expertise en Produit de Santé

Affaires Réglementaires & Qualité

As a Consulting Regulatory Affairs & Quality firm and a training center, Aspe Conseil brings together consultants with experience in regulatory affairs and quality in the health product industry. Armed with 30 years of experience, our firm’s goal is to guide you and provide you with the tools you need to meet the requirements related to the regulatory and quality environments that are present at each step of your products’ life cycle.  

Nos Prestations

Conseil en Affaires Réglementaires & Qualité

Conseil

Our consultants provide technical regulations support to help put together the development and the market launch strategy adapted to your product. 

Rédaction & Suivi

Working closely with you, we draft the registration file, submit it to the authorities and follow up the submission.  

Qualité

We help you set up your Quality Management System and assist you during the certification audit according to European and International standards. 

Formation

We offer training courses for the regulations, standards and guidelines that structure your business allowing you to apply them and anticipate changes.       

Nos expertises

Produits de Santé

Médicament

Beyond an essential experience in allopathy, we also have long-standing expertise in homeopathy and phytotherapy as well as a solid base in biotechnology.  

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Dispositif Médical

Thanks to our multidisciplinary team, we handle medical devices from class I to class III: active/non-active devices, implantable devices, IVDs, connected devices, and devices combined with medicinal substances.    

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Complément Alimentaire

We can help you adapt to a new regulatory environment (health claims) with our particular expertise in plant-based products.  

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Produit Cosmétique

We help cosmetic product manufacturers apply the European regulation 1223/2009/EC (Good Manufacturing Practice, product information reports, qualified person, and safety evaluation). 

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Nos Références

Ils nous ont fait confiance

  • kasios
  • armor proteines

(FR)