Services

• Pre-Clinical and Clinical Development
• Registration Submissions and Support
• GxP and Regulatory Consultancy
• CRO Qualification
• Preparatory regulatory audits
• Due Diligence Audits

We provide experience & support with the following regulatory submissions.

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• IND
• DMF
• Annual Reports
• PSUR
• NDA
• BLA
• PMA
• ANDA
• eCTD