+390677209020 | +39 0267380552 info@direnzo.biz | sedemilano@direnzo.biz

Lingua

Consulenza Regolatoria
Our services of
Regulatory Consultancy

Di Renzo Regulatory Affairs is able to offer long-range services with maximum flexibility. Clients’ assistance is built on the company’s individual interests and specific needs.

Our company is formed by multiple units dedicated to the different sectors. The know-how and expertise of our professionals ensure attentive assistance and advice that can cover the whole life cycle of the products, from development to marketing, up to post-marketing operations.

The strict cooperation between units allows quick and full support, also in case of borderline products and for their regulatory classification.

Moreover, Di Renzo Regulatory Affairs cooperates with many regulatory consultants in all EU countries and in many extra-EU countries, thus ensuring international support.

The main services offered are:

  • regulatory advice (human medicines, veterinary medicines, medical devices, in vitro diagnostics, food supplements and related products, cosmetics, PMCs, biocides)
  • vigilance (pharmacovigilance for human and veterinary medicines, medical device vigilance and surveillance, cosmetovigilance, foodvigilance and phytosurveillance)
  • scientific information and promotion
  • clinical Trials
  • Quality Management Systems
  • translations
  • training courses
  • Regulatory Privacy.

Regulatory Consultancy for the sector of medicines for human use.

Advice on current Italian and European regulations and on the evolution in the biocides sector.

Our specialists at the service of veterinary pharmaceutical companies.

We cater to all companies that produce, market or intend to import cosmetics.

A team of engineers and specialists in the field of medical devices and IVD.

Our consultancy is aimed at companies producing and importing food supplements.