We are a partner of choice for the below models:our success is built on our partners’ success! We offer our R&D and manufacturing capabilities to pharmaceutical companies worldwide via: A. LICENCE & SUPPLY We develop EU/US CTD dossiers and supply the finished product from EU/USA approved manufacturing facilities. We have already developed in excess of 140 formulations (100 molecules). B. CO-DEVELOPMENT CONTRACT DEVELOPMENT We offer our R&D and manufacturing capabilities to provide products specifically chosen by our partners. This is particularly attractive to our partners for complex technologies like Long Acting Injectables, Modified Sustained Release Oral Solids and Ophthalmics. C. LIFE CYCLE MANAGEMENT ENHANCED PATIENT COMPLIANCE We offer our technology platforms to develop existing products in new delivery systems. This supports the life cycle management of brands and also assists in the improvement of patient compliance. D. OTHER SERVICES: Corporate Quality Management Drug Safety Intellectual Property Services Pharmacovigilance Quality Control Services Regulatory Affairs Scientific Operations Services Third Party Auditing -Providing compliance with national and international standards and legislation -Providing compliance with internal procedures. -Schedule, performance, support and report on internal audits in order to verify that the site operational management systems comply with the requirements of current GMP, ISO 9001 and ISO 14001 standard. -Development of the master documents SOPs and Protocols of the Organization’s QMS concerning the main quality affairs processes (“change control”, “customer complaints”, “corrective preventive actions”, “risk management”, “deviation investigation reports”, “suppliers’ complaints”, Vendors’ qualification”, “Personnel Training”, “Annual quality product reviews”, “hygiene rules as defined in Pharmaceutical legislation”). Product Quality Operations -Liaison support between client’s company (Pharmaceutical) and third party subcontractors to ensure compliance to Regulatory requirements, industry standards (GMP) and client company’s expectations. -Development of Quality / Technical Agreements between Pharmathen and third party manufacturers (TPM) as well as between Pharmathen and clients and/or clients’ affiliates. -Coordination and collaboration in all quality aspects concerning new product technology transfers between development site and commercialization site within organization and between organization and third party manufacturers (TPM). -Support new product introductions at the TPM sites and cooperate in the introduction of new analytical method to pace with times and new regulations requirements. Quality Assurance -Development of the master documents SOPs and Protocols concerning the performance and reporting on Process Validation, Cleaning Validation, Product Quality Results Review and generally other validation activities. -Development of the master documents SOPs and Protocols concerning the Environmental controls- Water treating systems - Process Validation & Product Quality Results Review of commercial batches. -Development of the master documents SOPs and Protocols concerning the executing, monitoring and reporting on DQ - IQ - OQ - PQ - Calibrations for machinery & production areas. Terms of use Data Protection Πολιτική Προστασίας Προσωπικών Δεδομένων Cookie Policy Contact us Change your cookie consent Annual Modern Slavery Statement Copyright © Pharmathen SA 2018. All rights reserved