PharOS Ltd

About PharOS Ltd

PharOS is a privately owned pharmaceutical company, developing, manufacturing and supplying Generic, Over the Counter and Value-Added Medicines with a global portfolio of more than 84 products and over 8.490 marketing authorizations in more than 103 countries worldwide. In addition, PharOS is providing value added services in the field of Product Development, Regulatory Affairs and Business Development Consulting.

  • GR
  • 2015
    On CPhI since
  • 1
    Certificates
  • 100 - 249
    Employees
Other
Contact info

Products from PharOS Ltd

  • EU eCTD Dossiers with Finished Product Supply

    Product EU eCTD Dossiers with Finished Product Supply

    1. Out-licensing of our eCTD Dossiers covering various stability zones (including IVb), including supply of finished products (from manufacturing sites in Europe with various cGMP certifications from High Regulated Authorities worldwide)
    2. Early and first to launch opportunities (generics)
    3. A continuously increasing pipeline of products

  • CMO Services

    Product CMO Services

    CMO services could be offered for Oral Solid forms - especially for Oncology products - in PharOS manufacturing plant in Malta.
  • Regulatory Affairs Services

    Product Regulatory Affairs Services

    PharOS Ltd. offers a wide range of services which includes regulatory affairs. Features: it enables to ensure that your dossier reaches marketing authorization status at the most time efficient and cost effective manner. Functional submissions outsourcing: applicable for pre-marketing submissions including regulatory due diligence and regulatory strategy design. Full service submissions outsourcing: suitable for marketing authorization applications through CP/DCP/MRP/NS and post-marketing authorization maintenance including variations, renewals and notifications. Project based outsourcing: task oriented activity where outsourcing is limited to specific tasks including update of spc & pil information and label artworks, review of promotional materials, pricing and reimbursement, eCTD preparation and publishing. Staff augmentation outsourcing: expand current capacity to meet short or long term business needs.
  • Business Development

    Product Business Development

    PharOS Ltd. offers a wide range of services which includes business development. Features: it provides new opportunities and growth potential to clients. The experienced managers continuously seek, identify and assess individual products and potential new markets. The broad network of professionals, located in strategic geographical positions, bring together companies in order to maximize both parties' return on investment. Licensing-In: the team carries out an extensive research to reduce your risk to minimum. Licensing-out: it helps to identify the suitable market segment for each client. Ventures: it is an “excellence center” that gauges beneficial partnerships based on needs. Their role is to liaise between diverse companies with common interests and mission to negotiate and conclude deals.
  • Batch Release Services

    Product Batch Release Services

    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.

  • Chemistry Manufacturing and Controls (CMC) Services

    Product Chemistry Manufacturing and Controls (CMC) Services

    PharOS Ltd. offers a wide range of services which includes chemistry, manufacturing and controls. Features: it uniquely qualified to assist in managing CMC needs. The skilled practitioners provide companies with the in-depth experience they need to ensure the robustness of their CMC capabilities. Dossier compilation: communication with api & finished product manufacturer, raw data evaluation for ema guideline and eu authorities compliance, co-ordination with external experts for non-clinical & clinical overviews, modules 2-5 compilation in eCTD format. Dossier evaluation/ upgrade: review of raw data, identification of deficiencies, address major issues prior to receipt of authorities' comments, ensure smooth registration procedure with short clock-stop. Dossier registration procedure: assessment on authorities comments, co-ordination with api, finished product manufacturer and cro, evaluation of responses, compilation of response documents for modules 2-5. Medicinal product life-cycle: life cycle management, gap analysis, variations.
  • Pharmacovigilance Services

    Product Pharmacovigilance Services

    PharOS Ltd. offers a wide range of services which includes pharmacovigilance. Features: 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, submission of product information to the xevmpd. Collection, processing and evaluation of adverse events (AEs): international and local literature weekly review, processing of individual case safety reports (icsrs), electronic reporting of individual case safety reports (icsrs) to ema and component authorities via EVWEB service. Risk management system (RMS): preparation and submission of risk management plan (rmp), preparation, translation and submission to health authorities of dear health care professional letters. Training/audits: tailor-made training to suit your needs in pharmacovigilance, pharmacovigilance processes & systems audits.
  • Product Development Services

    Product Product Development Services

    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 20 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

PharOS Ltd Resources