Kersten Compliance Services, LLC
www.kerstencompliance.comScience based regulatory service consultancy focused on CMC, non-clinical and clinical product development for novel technologies. Gene Therapy Comparability Protocols and Reports Vaccine Comparability Protocols and Reports FDA/EMA Meeting Briefing Book Packages Product Investigations and Deviation Closures FDA Information Requests Product Gap Assessments
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Science based regulatory service consultancy focused on CMC, non-clinical and clinical product development for novel technologies. Gene Therapy Comparability Protocols and Reports Vaccine Comparability Protocols and Reports FDA/EMA Meeting Briefing Book Packages Product Investigations and Deviation Closures FDA Information Requests Product Gap Assessments
Read more
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2018
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