Electronic Regulatory Submissions

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ServiceDescriptionFurther Information
Kompass Regulatory Services Ltd

Contact: Barry Geoghegan

T: 0906 66 34100.
E: rmcentire@kompassreg.com

Ardsallagh Business Park,
Athlone Rd.,
Roscommon,
Ireland

REGULATORY & CLINICAL SERVICES

Pharmaceuticals, Medical Devices & Combination Products

  • Electronic Common Technical Document (eCTD)
  • Clinical Trial Applications, IMPD, Bioequivalence studies, Investigator brochure, IND,
  • Clinical and non-clinical overviews & summaries
  • Licence registrations and maintenance in Europe & U.S- National, MRP, DCP, Centralised, CE marking, DMF, EDQM
  • Readability testing/PIL testing/mock-up creation, SmPC sourcing & harmonization
  • Product Quality Review Reports/Annual Reports
  • Controlled Substances licensing & Management
  • Due diligence, SOP preparation, Site Master File
    & Auditing
  • Pharmacovigilance
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    Pharma-EU s.r.o.

    Contact: Kurtis Kinsey

    T: 00 420 257 533 768
    E: kurt@pharma-eu.com

    Malostranske Namesti 23
    Prague 1
    118 00
    Czech Republic

    Expert European regulatory services ready to partner with your company.

    • European procedure scheduling and coordination.
    - CPs, DCPs or MRPs.
    • Dossier GAP analysis and conversion to CTD.
    • eCTD conversion and publishing using Extedo.
    • Czech/Slovak market regulatory expertise from development to post marketing.
    • Readability testing of Patient Information Leaflets (English, Czech, Polish, French, Spanish and Dutch).

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    Pharmalink Consulting

    Contact: Kevin O’Toole

    T: +44 (0) 1628 860 300
    E: kotoole@pharmalinkconsulting.com

    Vandervell House
    Vanwall Business Park
    Maidenhead
    Berkshire
    SL6 4UB

    Pharmalink Consulting is the world’s largest independent Regulatory Affairs Consultancy.
    We provide Regulatory Affairs support services to Healthcare companies globally.
    Our Clients benefit from our top-quality interim Regulatory Affairs staffing solutions and Consultancy Services.
    We have offices in the USA, UK, India and Singapore.
    In addition, we have developed our our ‘PAN’ – a network of Regulatory Affairs consultants in over 100 countries to offer local assistance, advice and support to our clients who may be expanding to new and emerging markets.

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    TRAC Services Ltd

    Contact: Natalie Grogan

    T: +44 (0)1209612650
    E: info@tracservices.co.uk

    Pool Innovation Centre
    Trevenson Road
    Pool
    Redruth
    Cornwall
    TR15 3PL

    Created in 2001, TRAC provides a full range of EU Regulatory Affairs Consulting Services to the Pharmaceutical, Biotechnology, Healthcare and Medical Device Industries. Our portfolio of regulatory services covers all stages of the product lifecycle and is delivered by specialists in their field with the relevant knowledge and experience.

    TRAC takes a fresh approach to consulting, providing long term or interim regulatory resource off-site. We personalise every project to ensure it meets the exact needs of our clients and are committed to delivering exceptional service quality that will change the way you think about regulatory consultancy services.

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    Wainwright Associates Ltd

    Contact: Dr Chris Wainwright

    T: +44 (0)1628 530554
    E: enquiries@wainwrightassociates.co.uk

    Wessex House,
    Marlow Road,
    Bourne End,
    Buckinghamshire,
    SL8 5SP,
    U.K.

    Wainwright Associates provides consultancy to the pharmaceutical, medical device and healthcare industries. We offer a professional and flexible service that is customised to our clients' needs. Our consultancy service includes: Product Development Planning, Regulatory Affairs, Pharmacovigilance, User Testing, Licensing

    We are able to carry out both short and long term contracts and can provide additional resources for in-house projects or manage new programmes of work for you.

    Wainwright Associates consultants are highly qualified and experienced in most therapeutic areas. The company handles projects in pharmaceuticals, both small molecule and biotech, medical devices, diagnostics, herbals, food supplements and cosmetics. Wainwright Associates has a dedicated in-house team and a solid network of local advisors in over 60 countries of the world.

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