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Regulatory Management
• Marketing authorisation management
• Regulatory submissions
• Audit management
• Non manufacturing GMP and SOP’s
• Artwork generation/management
• Provision and management of QP
• Batch release management
• Licenses to operate in EU.
• MA dossier management
• Regulatory advice and general GMP guidance


SERVICES

Sourcing and negotiating licenses/dossiers deals

Dossier due diligence and updating

Facility GMP inspection preparation

Technical transfer of product to new/trigger facility

Regulatory affairs activities and strategy

Pharmacovigilance and medical reporting

Project and budget management

Contractual requirements and negotiations

Responsibilities of MA holder management

Sales order processing and physical distribution


Partner companies:     PharmaDreams

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United Kingdom
Atrium Court, The Ring
Bracknell, Berks
UK RG12 1BW

p. +44 (0)870 7524105

f. +44 (0)870 7524106

  
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