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Contracts
Provision/management of agreements for:
• Qualified Person
• QP Pharmacovigilence
• Medical
• Auditors
• Batch release facility
• Sample retention facility
• CDA’s
• Technical – API, Auditors, Dose Facility
• Supply Agreements – API, Dosage forms
• EU warehouse/logistics companies
• Customer agreements
• Supply Agreements
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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
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