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SOLUTIONS & EXPERTISE

Combination Products

Delivering tailored solutions to our clients to help them navigate regulatory complexity and speed time to marketing authorization
Our solutions

Services

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Drug & Device Strategy Alignment


Lead the meetings preparation & due diligence assessments for medical device products.

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Quality Systems & Remediation


Assist with Quality System documentation development including expert technical reviews of software development procedures.

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FDA Submissions​

Prepare or assist in the preparation of regulatory submission for medical devices

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FDA Meeting Preparation & Engagement


Assist clients in preparing for FDA meetings and FDA Advisory Panel meeting.
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Our expertise

Biologics Consulting Advantage

Senior Level Talent
Fulltime In-house Consultants
Multidisciplinary Support
Global Portfolio & Proven Track Record 
+100 Years of Combined Experience in Regulatory Projects
Regulatory Support in all Phases of Development
Frequent FDA Interactions
Former FDA Consultants

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