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Technical Transfer
• Implement our approved protocols
• Steps to ensure process transferred exactly
• Collation of data requirements
• Assessment of issues/resolutions
• Ensuring specifications are met
• Method transfer to batch release facility
• Co-ordinating with regulatory and purchasing
• Working with third party suppliers
• Keeping to time table/informing project manager
• Seeing it through to first commercial production


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

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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