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
- Implementation of GDP-based quality system
- Responsible Person (RP) services
- Applying for a Wholesale Distribution Authorisation (WDA)
- and much more…
GET IN TOUCH WITH US...
Xyzum Sp. z o.o.
18 Twarda Street
Registration No. (KRS): 0000710287
Tax & VAT ID (NIP): 5213807114
Statistical No. (REGON): 369036644
tel.: +48 22 122 85 00