Product Development Services

Product Development Services
Product Description

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

  • GR
  • 2015
    On CPHI since
  • 3
    Certificates
  • 250 - 499
    Employees
Company types
Generics/Biosimilars Manufacturer
Pharmaceutical company
Primary activities
Contract Manufacturer
Out-licensing specialist
Pharmaceutical Company (generic finished products)
Regulatory Affairs
Specifications
  • Selling Points
    Quality Service; Reputation
  • Supplied from
    Greece

PharOS Ltd

  • GR
  • 2015
    On CPHI since
  • 3
    Certificates
  • 250 - 499
    Employees
Company types
Generics/Biosimilars Manufacturer
Pharmaceutical company
Primary activities
Contract Manufacturer
Out-licensing specialist
Pharmaceutical Company (generic finished products)
Regulatory Affairs

More Products from PharOS Ltd (10)

  • 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...
  • 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, locate...
  • 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 product...
  • 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 c...
  • 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 loca...
  • Out - Licensing

    Product Out - Licensing

    Out-Licensing of Generic and other Value Added Pharmaceutical Products
  • Contract Manufacturing Services

    Product Contract Manufacturing Services

    To learn more about our Contract Manufacturing Services in Malta, please contact: nfessa@pharosgr.gr
  • Finish Dosage Dossiers for Out-Licensing

    Product Finish Dosage Dossiers for Out-Licensing

    For our product portfolio please contact: businessdevelopment@pharosgr.gr
  • 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....

PharOS Ltd resources (2)

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  • Product Analytical Development Services

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  • Product Biotherapeutics

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    Analytical services 

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