 Di Renzo Regulatory Affairs, established in 1985, avails itself of a vast and professional working staff, as well as several expert consultants who have a longstanding experience in the field of all aspects of regulatory affairs.
We offer our experience to companies operating in the health sector in order to obtain the necessary authorisations to allow companies to commercialise their Medical Devices.
As well as Medical Devices, Di Renzo Regulatory Affairs also deals in the following areas:
- Medicinal products for human and veterinary use
- Advice and assistance with clinical trial applications
- Due diligence
- Preparation of the necessary documentation regarding certificates and licences (e.g. Free Sale Certificates, GMP certificates, and narcotics licences)
- Medical devices
- Biocides
- Cosmetics
- Food supplements
- Dietetic products.
- Local pharmacovigilance requirements for medicinal products
- Pricing
- Translations
- Organisation and printing of promotional material (advertising material, SPCs, PILs, labels etc) through our in-house IT and graphic department
- Assist clients with contacts in other countries through our international network of consultancies, with whom we co-operate on a regular basis.
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