Small Italian SME active in R&D in the pharmaceutical sector has developed a new medicinal product for EU and USA market, for paediatric use, for the treatment of interstitial cystitis. The SME is looking for an agent in the USA able to assist in filing an FDA (Food and Drug Administration) request and offering consultancy services.
The present business request comes from an Italian SME operating in the pharmaceutical sector. The company develops innovative pharmaceutical projects, by providing regulatory, clinical and pharmacovigilance services. Among company’s services are:
-Analysis of the current and next legislation (Public Consultation)
-Nursing Assistance and support for pharmaceutical companies, Clinical Nurse Services (According to the International Council of Nurses - ICN)
-Research & Development of New Products;
The company is now working on the development and registration of a medicinal product for human use, for a rare disease: the treatment of interstitial cystitis. The company intends to distribute the product in the European Union and in the USA, for paediatric use. The product relies on the employment of an active substance like pentosan polysulfate sodium, but with a new innovative composition.
The present business search aims at the identification of a suitable medium/long term partner in USA able to assist the Italian company in filing all the regulatory activities with the FDA. The partner should possibly also act as a consultant in view of launching the product on the USA market. The Italian company would like to sign a services agreement.
- Type of partner sought: The partner should be a USA agent or consultant, with registered office in the USA, operating in the health and medical sector; familiar with FDA procedures and regulatory activities.
The US agent/consultant should be able to follow the submission of request for FDA orphan designation, for an exclusive sponsor/applicant: the Italian company.
- Specific area of activity of the partner: The partner sought should be an agent or a consultant with resident address in the USA able to assist in all the regulatory activities requested by FDA, for registering the new Italian SME medicinal product. The partner should also offer consultancy services for entering the USA market. The Italian SME would like to sign a services agreement.
Later on, eventually, the partner could act as a co-partner distributor for the USA market.
Under development/lab tested
Granted patent or patent application essential
40 days ago - InnovateUK December sector competition: Open