• Home
• Asaf Shamsi

Personal information

• Wants

  Clients, who need a full line of specialized consulting services (see below), in the Pharmaceutical, Biopharmaceutical, API (Active Pharmaceutical Ingredient), Medical Device, and related industries. Also want to connect with organizations, companies, or individuals, who are looking for, strategic alliances, business collaborations, contract manufacturing, contract testing, contract research, R&D arrangements.

• Haves

  A pharmaceutical industry professional, who has worked for organizations, and as a consultant, to worldwide clients, in the pharmaceutical, biopharmaceutical, active pharmaceutical ingredient (API), medical device, and allied industries, to create facilities complying with international cGXP, (GMP, GLP, GCP), and achieve regulatory approvals, and market entry, in North America, (USA, Canada), the European Union, and other countries, Over 23 years of experience, in Conceptualization and Design, of Manufacturing, Testing, R&D Facilities, Quality Systems, (new and upgrading), cGXP Compliance, for FDA, (USA), TPD, (Canada), EMEA, EDQM, (EU), TGA, (Australia), MCC, (South Africa), WHO, BRIC, International Regulatory Affairs, preparation and handling of, regulatory submissions, IND, NDA, ANDA, MAA, Abridged MAA, DMF, EDMF, CEP, and other applications, (CTD, eCTD, or alternative formats), Outsourcing, Contract Manufacturing, Contract Testing, Contract Research, Arrangements, Due Diligence, cGXP Audits, Strategic Planning for Business Development, Knowledge of current industry regulations, as well as future policy shifts in several countries, Insight into how regulatory agencies think, and what data they will need to approve specific products, Personal contacts in international markets, and extensive experience in interacting with regulatory agencies in the USA, Canada, the European Union, and other countries, Strong project management, and interpersonal skills.

• Interests

  Pharmaceutical, biopharmaceutical, API, medical device, industries, intellectual property rights, generics, biogenerics, professional networking, reading, writing for industry-related publications, training, and education, community, and social work, music, travel, cultures.

• Groups

  

• Employment status

  Entrepreneur

Educational background

• Languages

  English (First language), Hindi, Gujarati, Urdu