PHARMA DATA

Pharma-Data is regulatory affairs and business development consulting company established in the year 2000
in the historical city of Lavrion in Greece. Our initial activity was the preparation of registration dossiers
and regulatory services.

During these years our horizons have been persistently widened challenging the today's expanded requirements 
of the pharmaceutical market for regulatory and business development expertise.
Following the continuously complexity of the pharmaceutical legislation and demands, Pharma-Data is focused on 
the provision of:

  • High-quality, state-of-the-art registration dossiers for generic pharmaceutical products
  • Top regulatory affairs consulting
  • Business development services
  • Licensing opportunities (-in & -out)

Our main goal is to offer top services to our partners, succeeding the establishment of critical agreements
and win-win collaborations between parties.

Regulatory Affairs

This was and still remains our primary field of activities! Trust our experience to secure your investment and meet your needs. We can cover for you the whole range of activities from API sourcing to the final MA of your products.

Outsource us for:

  • Contract development of generic products
  • Preparation of generic registration dossiers
  • Submission of the dossiers to the final MA
  • DCP/MRP running

Business Development

We are operating mainly as an intermediary between pharmaceutical professionals and experts.

Our wide network of associates and agencies enable us to provide top-of-line services such as:

  • Licensing-in & -out opportunities
  • Ready for submission registration generics dossiers
  • APIs sourcing
  • Contract manufacturing sourcing
  • Product development (process validation, analytical validation, stability studies etc)
  • BE studies (at collaborating CROs)
  • Export-Import activities

The establishment of strategic partnerships and alliances enables our maximum penetration to all generic markets of the territory of Europe, Africa, Asia, Middle East, US and Canada.

We are thankful to introduce you to our partners.

For cost-effective services, risk reduction, time-saving, faster up growth.

More specific, what we do is:

  • Extensive research for USE, API and FORMULATION patents (in-house and/or by specialized patent attorneys)
  • Extensive investigation in the best facility for Drug Product pilot and commercial batches contract manufacturing
  • Formulation development
  • Design and Validation of Analytical methods (according to ICH guidelines)
  • Robust and cost-effective manufacturing process development and optimization
  • Process validation (ICH guidelines)
  • Stability studies (ICH guidelines)
  • Compatibility studies / in-use stability studies
  • Bioequivalence studies (using the highest skilled specialized CROs worldwide)
  • Dossier compilation and submission
  • Preparation and follow-up of National, MRP and DCP applications
  • Post-approval regulatory support, (variations, updates, renewals etc)

Please feel free to ask us about our updated list of available and under development dossiers.
All available information can be offered to you upon request.
Don't hesitate also to send us your wish list.

Αγγελίες

Κλάδος: Φαρμακευτικές
Έτος ίδρυσης:
Αριθμός εργαζομένων:
Ιστοσελίδα: http://www.pharmadata.gr
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