According to the pharmacist laws and guidelines all medical preparations that are marketed in Israel need to be registered in the National Pharmaceutical Registry, after safety, quality and effectiveness have been proven.
BioPlan specializes in all types of pharmaceutical registrations, including on-going management of the files and licenses in full compliance with the Israeli MoH and its guidelines.
All BioPlan activities are carried out under our unique in-house ISO 9001 quality system, with strict data confidentiality and discretion.
All electronic data is secured with routine backs performed in a secure environment.
This Service Includes:
Submission and management of new products (files), renewals and variations of the products.
Compiling modules for a CTD type file including quality, pre-clinical and clinical summaries.
Development of regulatory strategies for successful submissions of files to the local authorities.
Management of a system to control and update all printed materials of registered products including Israeli MoH approval, and coordinating with the product manufacturer, translators, and the printers.
Obtaining and managing “First Batch Approval” (The marketing authorization)
Our appointed pharmacist will coordinate with your QPPV, your QP batch release and your pharmaceutical warehouse in order to ensure full compliance, utilizing the shortest possible time frames for your product.