MARKET ACCESS & REGULATORY AFFAIRS
YOUR PARTNER FOR SUCCESSFUL PRODUCTS
SCF is a consulting company, specializing in regulatory affairs and market access. SCF is a point of reference at the national level for companies working in the fields of medicines, medical devices, dietary supplements, cosmetics, biocidal products and medical-surgical aids.
Our mission is to support our clients in the regulatory pathway, with the aim to reach the desired results, working in full compliance with the regulatory field.
Our strength is our know-how, which comes from a combination of knowledge and experience, strengthened by continual updating in the regulatory field, which is always in evolution, because our aim is to never remain behind, but always to be one step ahead.
Thanks to our excellent knowledge of the relevant legislation, which ranges from clinical studies to market access, we support companies from the planning phase and optimization of medical products, medical devices, cosmetics, dietary supplements, biocidal products and medical-surgical aids.
The registration processes for medicines, medical devices, dietary supplements and cosmetics are rigorously regulated and need the understanding of all the legislative aspects, for a correct application of regulations.
The identification of the strategy for market access begins before obtaining authorization, because we think that the timing in parallel with pricing, are the fundamental components of a successful strategic analysis.
Pharmacovigilance is all the activities finalized for identifying, evaluating, understanding and preventing adverse effects correlated with the use of medicines, with the aim of assuring a favourable benefit/risk relationship for the users.
The implementation of a quality system is an added value for companies and a guarantee of quality for their clients. The international standard ISO 13485 is the reference standard for the management quality system, specific for companies that operate in the medical sector.
SCF is a point of reference for companies that want to learn more about specific pharmaceutical themes through tailored-made or in-house training courses. We also manage complete events aimed at the involvement of medical professionals.