AR (Assogna-Rossetti) Joint venture

AR (Assogna-Rossetti) Joint venture: Service provider in Pharmaceutical Sciences

SFG Consulting Ltd, founded by Giuseppe Assogna, MD and Rossetti Consulting Sas founded by Stefano Rossetti, MD have agreed to create a joint venture in order to capitalise on the vast experience in the Pharmaceutical sciences providing clients with a larger set of specialized services and addressing the client needs with sense of urgency, high quality and respect of timelines. The two companies will remain independent but working together with a larger team exploiting the different fields of expertise of the two founders together with a selected group of experts and KOLs. The client will be free to contact one of the two companies that will represent his main contact reference and, at the same time, will access to the joint venture team and the full span of services. The new Joint Venture provides consultation for and support to Pharma, Biotech, Food Integrator Companies and CROs in the following fields: product development, medical-scientific and regulatory affairs, clinical trials, medical writing, scientific support to licensing activities, scientific rationale for IP, bibliographic and scientific documentation services, medical support to Pharmacovigilance activities on drugs, natural compounds, food integrators, strategies for registration, price negotiation, pharma-economics and market access, business development, etc.

Mission

  1. Develop and support projects and programs in Pharmaceutical Affairs
  2. Pursue excellence in providing high quality consultancy services to their clients
  3. Meet clients’ needs with the appropriate sense of urgency, client orientation and top level services in order to be considered a reliable and highly qualified partner
  4. Provide on demand the support of a “qualified network” of experienced professionals and experts giving the company the ability to participate in a diverse and integrated forum of projects.

Core Activities

The Joint Venture can deliver the following services:

  1. Assess the validity/robustness (strengths/weaknesses) of the Development Plan providing guidance for improvement in terms of medical/regulatory/marketing validity as well as attractiveness for investments.
  2. Guidance/contribution on preparation of an appropriate global integrated development plan: from target product profile to NDA/HRD and market access
  3. Medical support in in- and out-licensing activities including regulatory requirements, costs and timelines of clinical programs, and market competitiveness.
  4. Assistance in the preparation of a successful regulatory plan including the critical review of briefing books for scientific advices at National European regulatory bodies, EMA/CHMP, Canada, and FDA.
  5. Support in Medical Affairs activities, including clinical trials, and medical support to Pharmacovigilance
  6. Preparation of key documents: IMPD (pre-clinical and clinical sessions), Study protocols, Investigator’s Brochure, etc.
  7. Chairing and handling successfully scientific/medical advisory boards with key OLs and experts, Efficacy and Safety review Boards, etc.
  8. Large network of national and international experts in different therapy areas and in different disciplines of drug development and medical affairs including relationships with Scientific Societies, Public Institutions, Associations and Foundations
  9. Start-up foreign companies including corporate, administrative and medical affairs aspects
  10. Strategic advice, finalization and critical evaluation of price negotiating dossiers, including the ones for Regional Therapeutic Formulary (PTOR) and Local Formulary (PTO);
  11. Finalization and implementation of tools needed to support pharmaco-economic aspects (e.g. Cost analysis, Budget Impact Model, Publications, etc.).
  12. Market access

For further information on the AR Joint Venture please contact:

  • SFG Consulting Srl, Via del Serafico, 106 - 00152 ROMA (I)
    Tel: +39 06 97993752; Fax: +39 06 97993753; Mobile: +39 335 7273173
    eMail: This email address is being protected from spambots. You need JavaScript enabled to view it. WebSite: www.sfgconsulting.it
  • Rossetti Consulting Sas,  Via Appiani, 21 – 21100 Varese (I)
    Tel & Fax: +39 0332 231363; Mobile: +39 335 6215409
    eMail: This email address is being protected from spambots. You need JavaScript enabled to view it. WebSite: www.rossetticonsultingsas.it