Klassen Consulting, LLC


“During the time I worked with Dan Klassen I developed a high level of respect for his knowledge, savvy and insight into the regulatory affairs discipline. He demonstrated it during the time I worked with him and he has carried forward that expertise as he provided guidance and direction to numerous clients. Dan applies not only a solid set of regulatory affairs skills to his work but he brings qualities such as integrity and dedication that are instrumental in his success. I was particularly impressed with his appointment to an FDA advisory panel as an outside consultant. He is an expert you can trust with your most complex or straightforward project.”

P. Michael Dubinsky
Former FDA Deputy Director, CBER, Office of Compliance
Independent Consultant & Instructor, University of California, Berkeley, CA


“I have worked with Dan in several different capacities since 1997. He has been a client of mine, later a fellow employee of the same company, and an independent consultant who we regularly employ to augment or staff. In every capacity I have always found Dan to be extremely knowledgeable, diligent and a general delight to work with. I am happy to endorse not only his technical and regulatory capabilities but also his work ethic. I am pleased to think of Dan as both a great colleague and a good friend.”

David Chesney, Vice President, Strategic Compliance Services
Former FDA District Director, San Francisco District Office
PAREXEL Consulting, Massachusetts


“I have worked with Dan on a number of projects for the Strategic Compliance Services group within PAREXEL Consulting, both while he was a member of PAREXEL Consulting and more recently when he provided expert support as an independent consultant.

His integrity, expertise, professionalism and work ethic are all of the highest level. He has an exceptional combination of experience in quality management systems and regulatory affairs along with extensive scientific training.”

Mark Lookabaugh, Principal Consultant
Former FDA Director, Compliance Branch, New England District
PAREXEL Consulting, Massachusetts


"Dan is a regulatory expert in early stage pharmaceutical development, especially regarding GLP requirements and early-stage regulatory filings for new drugs/biologics. Dan and I both worked for a large contract research organization, during which time we collaborated on a consulting engagement to comprehensively document GLP and GCP practices and procedures for a vaccine product under development by an international pharmaceutical company. He directed and supervised one of 3 consulting sub-teams, interacted effectively with our client's managers, assured the quality of project deliverables for his sub-team, and participated in presentation of project results to our client's executive team. Subsequently, I have partnered several times with Dan in his current role as President of Klassen Consulting. His knowledge is always incisive, at an expert level, and his advice is delivered clearly and succinctly; he is highly respected by clients."

Annette Horner
, Practice Partner at Barnett Consulting /PAREXEL
Sr. Director at Compliance Implementation Services (CIS)


Cara Therapeutics, Inc. is an emerging Biotechnology company located in Connecticut.  In preparation for approaching Phase I and Phase II Clinical Trials, we required CMC assistance related to documentation review and quality issues.  We used Dan Klassen of Klassen Consulting who assisted us by:

·       Reviewing the CMC section of documents needed for European Approval for a CTA, specifically:

·            Review of stability data and recommendations for successful path forward

·       Review/confirmation of study design for additional stability studies consistent with ICH guidelines

·       Reviewing the stability data package for a second product and Regulatory strategy for path forward to support use of existing drug product for new clinical trials

·       Conducting GMP Audits and a Batch Record Review of Foreign Contract Manufacturing Organizations

During the course of our relationship, we have found Dan to be responsive to both telephone and e-mail inquiries and provided high quality reports on time.  He is pleasant to work with and his opinions were well-regarded within Cara and as well as by the CMOs that were audited.

Stephen O’Connor, PhD, Associate Director, Chemistry
Cara Therapeutics, Inc.,
Shelton, CT 06484


“Dan brought his vast pharmaceutical regulatory experience to our project at a time when we needed his skills the most, to put together an appropriate strategy and the documentation package to gain speedy approval for our sNDA application to the FDA. He assisted on the strategy end as well as in the creation of a thorough, comprehensive and detailed submission for our product that was accepted by the FDA allowing us to launch on schedule.”

Jesse Ahrendt, Executive Director of Operations
Canyon Pharmaceuticals, Inc., Maryland


“I hired Dan as an auditor (at Avrio Biopharmaceuticals) to review our quality system in a start up pharmaceuticals and medical device company. He was very professional, personable, and very detail oriented. Dan did a fantastic job identifying the deficiencies and areas for improvement. I will definitely use Dan's services in the future when I need an independent auditor services.”

Yasamin Ameri, Principal Consultant
Quest International Consulting, California
FDA, Consumer Safety Officer


Rx Kinetix, Inc. is a small emerging drug company, preparing for Phase 3 clinical trials and an NDA submission.  We required assistance with CMC related issues in preparation for our EOP2 FDA meeting.  We utilized the services of Dan Klassen who was able to:

·       Assist with identification of potential issues that could be raised by the FDA;

·       Prepare questions and a regulatory strategy to address these potential issues;

·       Develop the CMC section of the briefing document to educate the Agency and support the proposed regulatory strategy;

·       Develop the briefing document within a minimum amount of the time so as to meet the pre-meeting filing requirement;

·       Assist with preparation, rehearsal and understanding of the meeting process; and

·       Assist with the recording and preparation of internal meeting minutes.

As a result, the FDA had no serious concerns regarding the CMC regulatory strategy and provided only minor comments and recommendations.  We are very pleased with Dan’s work, guidance and the project outcome.

Ms. Deborah Abbott-Brown, Vice President, Pharmaceutical Operations
RxKinetix, Inc.,
Boulder, CO


“Highly knowledgeable compliance expert; can handle ambiguity; can get an organization to accept and follow his lead, even when he is not hierarchically in charge.”

Hans Engels, CEO
SwissCaps USA, Inc., Florida


“Working with Dan is a real pleasure. He is knowledgeable, works on a timely basis and keeps everyone grounded and calm. I learned much from my interactions with him in the regulatory area for drug products, always in a very friendly and collegial manner. His work excels.”

Joseph S. Bertino, Jr., Pharm.D., F.C.P., Clinical Pharmacology and Legal Consultant
Bertino Consulting,
Schenectady, NY 12303


“Dan is a rare combination of RA/QA/QC expertise and business acumen.  He clearly possesses a thorough understanding of the bigger picture of the industry, from product development to licensure and post-marketing strategies. No wonder he is enjoying massive respect among his peers and the loyalty of his business associates. If you are looking for a highly knowledgeable and experienced executive/management consultant, be sure to browse through Dan’s impressive list of skills and accomplishments. Klassen Consulting might be just the answer to your needs.”

Roxana Lampert, Principal
SNIBO Web Solutions, California