- 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
- Product Development
- Chemistry, Manufacturing & Controls
- Business Development
- Contract Manufacturing
- Regulatory Affairs
- Batch Release
- Supply Chain Management
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.
Chemistry, Manufacturing & Controls
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.
- 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
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.
At PharOS we provide Contract Manufacturing services for our site in Malta for the following categories:
- Technology Transfer of customer’s finished products
- Technology Transfer of customer’s products with dossier under development
- Stability services
- Batch Control and Release services
Our facilities are cGMP compliant for the manufacture of the conventional and oncology medicinal products (tablets and Hard capsules).
We have a variety of manufacturing equipment to handle several batch sizes.
Our packaging machines consist of fully automated packaging lines (primary, secondary, serialization, aggregation-including check weighing) for tablets and hard capsules in hot and cold forming materials and a Semi-automated line for filling, labelling and secondary packaging of the bottles.
PharOS as a CMO provides End-to-End Support during the entire manufacturing process with:
- Manufacturing Flexibility.
- High technical machine design know-how.
- Testing and release of API, excipients and final product.
- Stability testing according to ICH guidelines in state-of-the-art climatic chambers with continuous monitoring.
- Regular meetings with a dedicated team for monitoring the progress of the agreed steps.
- 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.
Our impressive track record makes us one of the most experienced Regulatory Affairs organizations in Europe.
- More than 740 DCPs/MRPs handled
- Average Validation Time 21 days
- More than 8.310 MAs registered or under registration worldwide
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.
- 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
- 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
- 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)
- 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.
We let numbers and data speak themselves for the quality of our services. Over the past decade we have processed:
- More than 265 RMPs
- More than 50 PSURs
- Weekly literature searches for more than 115 active substances
- Collaboration with more than 90 pharmaceutical companies worldwide
- More than 55 clinical / non-clinical overviews
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
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
- 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
- Shipping above 651.5 Million Units (2022) in various forms
- Delivering more than 2.600 orders annually (2022)
- Handling of more than 5.000 SKUs