Excellence in generic medicines

Dossier Licensing

We offer more than 40 generic drug products for licensing to our partners globally. All product dossiers are in EU-CTD format

Supply from EU

All our generic drug products are manufactured in Europe (EU) and supplied globally to our partners in their brand

Regulatory support

We provide our partners with full and comprehensive regulatory support at all phases of the product life-cycle

About us

GxMed Healthcare is a privately owned pharmaceutical company out-licensing its dossiers with supply of generic drug products to its partners worldwide.

GxMed Healthcare provides its partners with:

  • The highest standard EU-CTD Dossiers
  • EU-manufactured high-quality Products
  • On-time supply of finished dosage form (FDF) Products

Milestones

2008

GxMed Healthcare was founded as a pharmaceutical consulting company

2014

The company acquired the intellectual property rights for a portfolio of generic drug products

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GxMed Healthcare has grown significantly and added more products to its portfolio for out-licensing and supply and is today proud to be able to offer more than 40 generic medicinal products to partners around the globe.

We strive to fulfill our motto of ‘Excellence in generic medicines’ and deliver excellence in our work and to be of added value to our partners:

  • from first contact with our Business Development team
  • through the submission phase with our experienced Regulatory Affair team
  • to final supply of "full-service pack" finished drug products with our dedicated Supply Chain Management team

To GxMed Healthcare our partner is our most important asset and through our continuous dedication, we ensure loyalty and satisfaction for our partners.

Dossiers & Products

Our dossiers are all up-to-date and in the European CTD-format. For new submissions in EU, we provide the dossiers in the latest standard of eCTD-format. Additionally, we are constantly maintaining the dossiers up-to-date according to the current EU legislation, regulation and guidelines.

The dossiers are submitted for Marketing Authorization approval to health authorities worldwide and we assist our partners along the entire submission process in close collaboration with the local health authorities. We are proud to have a track record of fast, smooth and efficient submissions, minimizing the submission process and time-to-market for our partners.

All our products are manufactured locally and exclusively in Europe by our trusted and carefully selected CMOs. The products are delivered to our partners as “full-service-pack” and we strive to deliver:

  • in the highest quality
  • at the best price
  • always on-time

With the dedication and adaptation to constant changes, GxMed Healthcare makes it possible for their partners to maintain or even grow their position in a very competitive market place and ensure that GxMed Healthcare enjoys a preferred partner status.

We would be very pleased to receive inquiries for licensing, tech-transfer or other types of proposals for our products. Please contact us.

Important notice: Products protected by valid patents are not offered for sale in countries where the sale of such produts constitutes patent infringement. Availability may be restricted to certain markets or countries

Supply Chain Management

Our Supply Chain Management team’s expertise and professionalism are key to meeting the stringent pharmaceutical supply chain requirements:

supply
  • Pre-launch Coordination
  • Artwork Management Coordination between customers and CMOs
  • Launch Management
  • ERP Development / Maintenance
  • Production Planning Coordination with CMOs
  • Forwarding & Shipping of raw materials and finished products
  • Financial Control of supplies
  • Supply Chain Data Analysis & Reporting
  • Customer Service
  • Product Serialization Coordination with customers and CMOs

Regulatory Support

Our experienced Regulatory Affairs Department provide our partners with full and comprehensive regulatory support, at all phases of the product life-cycle to local health authorities worldwide:

  • 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, Pricing and Reimbursement, eCTD Preparation and Publishing
  • Our teams’ 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
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Once we have assured the successful submission and subsequent approval of our dossier, we then continue to strive to ensure the quality of the finished pharmaceutical product by providing our partners with the following support:

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  • Communication with the API and finished product manufacturer
  • 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
  • Handling of variations

Contact

How to reach us

  • 25 min. by taxi from BCN airport
  • 20 min. from Barcelona centre
  • Easy access from the AP-7 highway

Contact us

  • GxMed Healthcare Group
    Av. Corts Catalanes 8
    08173 Sant Cugat del Vallès
    Barcelona, Spain
  • +34 935 533 994
  • info@gxmed.com

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