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KLASSENCONSULTING.COM

Home - Klassen Consulting, LLC

Regulatory and Compliance Consultant to FDA Regulated Pharmaceuticals, Biotechnolgical and Biological Drug Product Industries

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CONTACTS AT KLASSENCONSULTING.COM

Klassen Consulting, LLC

Dan Klassen

16652 ●●●●●●ak Ave

Chin●●●●ills , CA, 91709

UNITED STATES

1909●●●●0543
1909●●●●0548
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Klassen Consulting, LLC

Dan Klassen

16652 ●●●●●●ak Ave

Chin●●●●ills , CA, 91709

UNITED STATES

1909●●●●0543
1909●●●●0548
dk●●●●●●@KlassenConsulting.com

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Regulatory and Compliance Consultant to FDA Regulated Pharmaceuticals, Biotechnolgical and Biological Drug Product Industries

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1

Experience - Klassen Consulting, LLC

http://www.klassenconsulting.com/3.html

Klassen Consulting, LLC. Klassen Consulting, LLC has extensive regulatory experience on over 350 projects including IND, NDA, ANDA,. BLA, DMF applications, supplements, amendments and annual reports. We have extensive regulatory compliance experience with more than 10,000 hours in regulatory authority inspections involving domestic and foreign regulatory agencies. Experience by Therapeutic Indication:. Oral Mucositis due to Chemotherapy. Proteins, Peptides, Monoclonals, Recombinants).

2

Testimonials - Klassen Consulting, LLC

http://www.klassenconsulting.com/4.html

Klassen Consulting, LLC. Former FDA Deputy Director, CBER, Office of Compliance. Independent Consultant and Instructor, University of California, Berkeley, CA. David Chesney, Vice President, Strategic Compliance Services. Former FDA District Director, San Francisco District Office. PAREXEL Consulting, Massachusetts. Mark Lookabaugh, Principal Consultant. Former FDA Director, Compliance Branch, New England District. PAREXEL Consulting, Massachusetts. Practice Partner at Barnett Consulting /PAREXEL. Review...

3

Home - Klassen Consulting, LLC

http://www.klassenconsulting.com/index.html

Klassen Consulting, LLC. Our Business is Working for You. Welcome to Klassen Consulting, LLC. Our business is dedicated to offering you realistic and practical advice, based on solid experience and a fundamental knowledge of the U.S. regulatory landscape as it pertains to Chemistry, Manufacturing and Controls (CMC) and Regulatory Compliance with current Good Manufacturing Practice (cGMP) for pharmaceutical, biotechnological, and biological drug products. Is it worth the risk. Lack of adequate Regulatory ...

4

Credentials - Klassen Consulting, LLC

http://www.klassenconsulting.com/1.html

Klassen Consulting, LLC. Klassen is an independent consultant specializing in the field of pharmaceutical, biotechnological, and biological drug products. With 27 years of industry experience in Regulatory Affairs, Regulatory Compliance and Quality Assurance, he advises clients on product development and regulatory strategies; regulatory compliance issues; meetings and negotiations with regulatory authorities; and crisis management and remediation situations. Prior to his consulting role, Dan held indust...

5

Services - Klassen Consulting, LLC

http://www.klassenconsulting.com/2.html

Klassen Consulting, LLC. Project and Crisis Management. Regulatory Consultation and Technical Writing. Chemistry, Manufacturing, and Controls (CMC) section of. Investigational New Drug Application (IND). New Drug Application (NDA). Biologics License Application (BLA). Drug Master File (DMF) development, amendments and annual updates. Post-Approval Change (PAC) supplements to NDA, ANDA, or BLAs. US Agent to Foreign API and Drug/Biotech/Biological Product Manufacturers/Suppliers.

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