SEARCH Homepage EXPERTISE PRODUCT DEVELOPMENT CHEMISTRY, MANUFACTURING & CONTROLS BUSINESS DEVELOPMENT REGULATORY AFFAIRS PHARMACOVIGILANCE BATCH RELEASE SUPPLY CHAIN MANAGEMENT PRODUCT DEVELOPMENT Developing Value Our comprehensive development activities includes early stage formulation and analytical development, technology transfer, scale-up, process validation and stability testing, CRO selection and clinical study design. WITH AN ONGOING PHARMACEUTICAL DEVELOPMENT PORTFOLIO OF MORE THAN 25 PROJECTS, WE MONITOR ALL DEVELOPMENT STEPS INCLUDING: Selection of API manufacturer ensuring supply of patent-non-infringing drug substance of the highest quality production standards, following Qualified Person (QP) inspection of the facility and via thorough assessment of the Quality Documentation (DMF) Qualification and selection of R&D centers and CROs Design and monitor of pre-formulation and formulation trials with a scope to achieve a patent-non-infringing formulation Analytical method development and validation Qualification and selection of finished product manufacturing sites that integrate the effectiveness of the technology transfer scale-up, balance geographically the first commercial launch opportunities and accredit the reliability of the commercial supply Design and monitor the manufacture of validation batches Design and oversight of clinical studies Data Collection and evaluation for Dossier Compilation CHEMISTRY, MANUFACTURING & CONTROLS CHEMISTRY, MANUFACTURING & CONTROLS (CMC) Science & Technology Our in-house experts are uniquely qualified in the field of Chemistry, Manufacturing & Controls (CMC). Our skilled staff comprises from scientists with the in-depth experience they need to ensure the robustness of their CMC capabilities. IN OUR STRIVE TO ENSURE THE QUALITY OF THE FINISHED PHARMACEUTICAL PRODUCT, OUR CMC EXPERTS ARE ASSIGNED WITH THE FOLLOWING TASKS: Communication with the API and finished product manufacturer Raw data evaluation for compliance with EU/ICH guidelines Coordination with experts for the non-clinical and clinical overviews’ preparation Compilation of modules 2-5 in eCTD format Assessment on Authorities’ comments for Modules 2-5 and design of response strategies Compilation of response documents for Modules 2-5 within set timeframe Gap analysis maintenance Handling of variations BUSINESS DEVELOPMENT Delivering Opportunities At PharOS we offer new opportunities and growth potential to our partners by offering the right partnership model to expand business. Our experienced managers continuously seek, process and offer tailor-made partnerships on products and markets. All our recommendations are based on solid research, cross-disciplinary expertise and a broad network of professionals located in strategic geographical positions, bringing together companies to maximize both parties’ Return on Investment (RoI). We liaise between diverse companies with common interests to negotiate and conclude deals both on a licensing-in as well as on a licensing-out model. REGULATORY AFFAIRS A Core Competency AT PHAROS WE PROVIDE FULL AND COMPREHENSIVE REGULATORY SUPPORT, AT ALL PHASES OF THE PRODUCT LIFE-CYCLE. OUR EXPERTS' SCIENTIFIC AND ANALYTICAL THINKING IS COMBINED WITH A COMPREHENSIVE RANGE OF REGULATORY AFFAIRS. Pre-submission activities including Regulatory Due Diligence and Regulatory Strategy Design Marketing Authorization Applications through CP/DCP/MRP/NS Post-Marketing Authorization Maintenance including variations, renewals and notifications as well as update of SPC & PIL information and Label Artworks, Review of Promotional Materials, Pricing and Reimbursement, eCTD Preparation and Publishing Our experts’ integrated background and up-to-date regulatory knowledge make us your number 1 choice for the complete regulatory activities range: from MAAs and renewal submissions and all types of Post-Marketing Applications, to the development of global regulatory strategies. We are a founding member of EuDRAcon®, a pan-European network of regulatory affairs companies, which further allows us to manage national applications across geographical Europe. TRACK RECORD Our impressive track record makes us one of the most experienced Regulatory Affairs organizations in Europe. More than 660 DCPs/MRPs handled Average Validation Time 21 days More than 8.490 MAs registered or under registration worldwide PHARMACOVIGILANCE Our experience your safety PharOS is able to collaborate with partners to meet the increasingly complex regulatory requirements in pharmacovigilance. Our full range of services offers flexible technologies, resourcing solutions, effective governance and continuous process improvement from early clinical development to marketed product support. IMPLEMENTATION OF COMPANY’S PHARMACOVIGILANCE SYSTEM (PVS) Qualified Person for Pharmacovigilance (QPPV) from pre-approval to post-approval (24-hours service) Provision of Contact Person for Pharmacovigilance (in Greece), to cover local requirements Company’s registration with EudraVigilance Electronic submission of Article 57(2) data Creation and review of Pharmacovigilance System Master File (PSMF) Standard Operating Procedures (SOPs) writing and review Consultancy services concerning working practices and legislation on Pharmacovigilance COLLECTION, PROCESSING AND EVALUATION OF ADVERSE EVENTS (AES) International and Local Literature Weekly Review Processing of Individual Case Safety Reports (ICSRs) Electronic reporting of ICSRs to EMA and competent Authorities via EVWEB Service Preparation and submission of Periodic Safety Update Reports (PSURs) Signal Management MEDICAL WRITING Non-clinical and clinical overviews & summaries as part of CTD, expert reports Addendums to clinical & non clinical overview for renewal applications Aggregate safety reports such as Periodic Safety Update Reports (PSURs), Risk Management Plans (RMP) Summary of Product Characteristics (SPC) and Patient Information Leaflets (PIL) TRAINING Tailor-made Training to suit your needs in Pharmacovigilance We provide full and comprehensive customer support, at all phases of the product life cycle. We create value across all areas of pharmacovigilance. TRACK RECORD We let numbers and data speak themselves for the quality of our services. Over the past decade we have processed: More than 210 RMPs More than 50 PSURs Weekly literature searches for more than 95 active substances Collaboration with more than 80 pharmaceutical companies worldwide More than 40 clinical / non-clinical overviews BATCH RELEASE Securing Quality Pharos has acquired a Certificate of GMP compliance from National Organization for Medicines for batch release of sterile and non-sterile products, as well as for imported medicinal products. The Pharos team with its extensive experience offers to its clients batch release of their products. SUPPLY CHAIN MANAGEMENT Supplying Value Worldwide Our Supply Chain Management department’s expertise and professionalism are key to our track record of First to Market launches worldwide, while at the same time meeting the stringent pharmaceutical supply chain requirements KEY TASKS OF PHAROS’S SCM DEPARTMENT: Demand Planning & Forecasting Pre-launch Coordination Artwork Management for own developments Launch Management ERP Development / Maintenance Production Planning for own developments Forwarding & Shipping of raw materials and Finished Products Financial Control of supplies Supply Chain Data Analysis & Reporting Customer Service Product Seriliazaition TRACK RECORD: Shipping above 467 Million Units (2020) in various forms Delivering more than 1.860 orders annually (2020) Handling of more than 2.390 SKUs STAY IN TOUCH BACK TO TOP CONTACT US Lesvou Str. (end), Thesi Loggos Industrial Zone 144 52 Metamorfossi Attikis, Greece T +30 210 6664667 | F +30 210 6664669 E info@pharosgr.gr NAVIGATION ABOUT US - THE TEAM - PHILOSOPHY & HISTORY PARTNERS PRODUCTS EXPERTISE NEWS CAREERS CONTACT CONNECT WITH US Kommigraphics + VG web things for PharOS Copyright 2016. All rights reserved. Terms & Conditions Privacy Policy