Services

Contact

Address:
Gaea | Clinical Ltd
One Broadcarr Road
Macclesfield
SK11 0AQ
United Kingdom

Gaea Clinical Trial Services LLC
97343, Saint-Petersburg,
ul. Matrosa Zheleznyaka, 57A, 122N

Tel: +44 1625 413 900
Fax: +44 1452 798 222
Mobile: +49 151 51 11 19 31
Email: ngg@gaea.co.uk

Regulatory

Regulatory

Gaea's Regulatory Manager can advise the sponsor on the EU and national regulatory processes for a trial from the initial application, through study conduct and to the end of trial notification:

  • Initial application to both central and local IRB/IEC including:

    • Full document collation
    • Assistance in the creation of patient-specific documents
    • Submission of application

  • Preparation of answers to any questions that arise from the central or local IRB/IEC
  • Input into substantial versus non-substantial amendments in the context of each country
  • Submission of notifications, amendments and substantial amendments, including safety information (e.g. CIOMs, ASR)
  • Completion of the End of Trial Notification

Our Recent Clients

Glycotope GmbH
DNAtrix Inc.
Genelux GmbH
Vifor Pharma UK Ltd
CureVac GmbH
MucoVax GmbH
BN ImmunoTherapeutics
Oncolytics Biotech Inc.
Cougar Biotech Inc.
Agios Inc.
Drug Royalty International
Allos Therapeutics Inc.
The Medicines Company, Inc.
Adventrx Inc.
Baxter Bioscience, Inc.
Merck Serono Oncology

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