MANAGEMENT TEAM EXPERIENCE
- Development of international suppliers in India, China ,US y UE
- Start Up in Latin America about Pharmion UK´s Vidaza. (Nasdaq: PHRM)
- Founded and managed pharmaceutical R&D, production and marketing start-up, leveraged to grasp business opportunities triggered by new regulations in Argentina (13th WW largest market).
- Positioned DRIBURG as one of the fastest growing companies in the market. Prepared business plan and achieved regulatory approval by local FDA in record time. Developed 3 lines or products: MIGRAINE-ONCOLOGY-PHLEBOLOGY. Acquired license to market migraine drug Sumatriptan from BMS and others drugs
- High experience in review, development and follow – up of new regulation affairs, OTC or ethics. .Experience in manages in sanitary authorities in Latin America, France, Pakistan and India.
- Preparation and evaluation of Pharmaceutical investment Projects.
- Signing confidentialy agreements with over a dozen interested companies, including two top 5 pharmaceutical companies.
- Licensing drugs in Korea, China and Japan.
TECHNICAL TEAM EXPERIENCE
- Liposomal molecules developement and recombinant proteins peguilation.
- 15 years experience where were developed over 800 pharmaceutical products.
- More tha 10 years of experince in develop pharmaceutical liposomal techniques and development own peguilated and clonation techniques and international patents.
- Long experience in auditories of validation process and ISO 9000 quality system.
- Experience in registration and regulation in oncology and biotechnology.
- Experience in building an oncology facility under GMP regulations.
- High capacity in development of analytic techniques for antiviral oncology drugs
- Experienced Pharmacist & Biochemist professional with broad experience in the pharmaceutical industry both in the technical and regulatory areas including national and international regulations: ANMAT /FDA / ICH / EMEA in Biosidus Laboratories.
- Experience in quality control of oncology drugs.
- Experience in Standard Operating Procedures (SOPs)
- Audits about fulfillment of procedures and Lay outs.
- Realization of continuous improvements guidelines .
- Control, closing and approval of documentation of production.
- Design of Pharmaceutical Plants.
