A new dimension
of pharma
innovation™

WE ARE A CONSULTING GROUP SERVING THE PHARMACEUTICAL AND BIOPHARMACEUTICAL INDUSTRY

We assist in drug development and
manufacture, we provide strategies
to expedite regulatory approvals and
help the companies staying compliant
through the entire product lifecycle.

IRELAND IS A WORLD-LEADING
CENTRE
OF EXCELLENCE FOR THE MANUFACTURE OF PHARMACEUTICAL AND FINE CHEMICAL PRODUCTS.

Our Irish-based company Xyzum
Regulatory Limited
specialises
in regulatory strategy, operational
management and achieving approvals.

WE CAN HELP YOU WITH:

  • Regulatory strategic planning
  • Regulatory intelligence
  • Assistance at R&D and manufacturing
  • Compilation of regulatory dossier
  • Preparation of Marketing Authorisation Applications (MAAs)
  • Procedure management: National, MRP/ DCP, Centralised
  • Worldwide NeeS and eCTD submissions
  • Regulatory lifecycle project management
  • Variations (administrative, quality, safety, line extension), renewals
  • ASMF and CEP submissions
  • Supervision and assistance at transfers of technology
  • Changes of RMS, transfers ownership
  • Tracking and monitoring
  • Due diligence and gap analysis
  • Wholesale Distribution Authorisation
  • and much more…

GET IN TOUCH WITH US...

Please call us at +353 89 242 68 58 (IE)
or +44 7438 91 91 31 (UK) or complete your
details below and we will get back to you.

logo xyzum
Xyzum Sp. z o.o.
18 Twarda Street
00-105 Warsaw
Poland

Registration No. (KRS): 0000710287
Tax & VAT ID (NIP): 5213807114
Statistical No. (REGON): 369036644

tel.: +48 22 122 85 00
www.xyzum.com
e-mail: info@xyzum.com

xyzum regulatory logo
Xyzum Regulatory Limited
1 Fry Place, Athlone, N37 X2E7
Co. Westmeath
Republic of Ireland

CRO number: 618861
Tax & VAT ID: IE 3520096UH

tel.: +353 89 242 68 58 (IE)
tel.: +44 7438 91 91 31 (UK)
www.xyzum.com
e-mail: info@xyzum.com






© 2018 Xyzum Group of Companies. All rights reserved.