• Assuring compliance with applicable standards and regulations (GMP (Good Manufacturing Practice) and GDP (Good Distributing Practice) guidelines and principals, Registration issues, GSP (Good Storing Practice)) and permanent liaising with regulators.
  • Executing Quality Agreements and drafting and implementation of internal procedures.
  • Providing legal opinions concerning the legislation governing the healthcare system and the pharmaceutical industry in Israel including extensive experience regarding the division of responsibilities between the different “players”(e.g Manufacturer/ Marketing Holder/ Importer/Wholesaler/ Distributor/Subcontractors/Pharmacist etc.).
  • Importing and release to market of pharmaceutical products and medical equipment including the responsibilities of the “responsible persons” (e.g. QP, RP etc.).
  • Establishing internal audit program.
  • Preparing for audits of regulatory authorities.
  • Achieving and maintaining all the required licenses, certificates and authorizations pursuant to any applicable law.