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Klassen Consulting, LLC
↗Livingston, TX, USA
Klassen Consulting, LLC is a specialized regulatory and compliance consultancy firm serving the pharmaceutical, biotechnological, and biological drug product industries. The firm provides expert guidance on regulatory strategy, CMC development, and quality systems, with a strong focus on helping clients navigate FDA and international regulatory requirements.
The company is particularly noted for its extensive experience in project and crisis management, including remediation for FDA 483s, warning letters, and consent decrees. They offer comprehensive services ranging from IND/NDA/BLA submission support to conducting cGMP audits for manufacturers, laboratories, and suppliers worldwide.
CLASSIFICATION
SIZE & FINANCIALS
Employees:1-50
Ownership:private
Status:operating
PIPELINE
Modalities:Small molecule, mAb, Recombinants, Peptides, Proteins
Active Trials:0
Trial Phases:-
FDA Approvals:0
EMA Approvals:0
CORPORATE STRUCTURE
Key Partnerships:NSF International (Joint Committee for OTC Drug GMP standards)
COMPETITION
Position:Niche Player
LEADERSHIP
Key Executives:
Dan Klassen - Principal Consultant
LINKS
Website:klassenconsulting.com
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