Gary Callahan
President/CEO
Gary Callahan has over fifty years of hands-on and management experience in the pharmaceutical manufacturing industry. Throughout his career he has implemented many GMP and SOP programs in several companies to meet compliance standards set by the FDA.

Mr. Callahan has managed key projects resulting in four state-issued drug licenses for different manufacturing companies in California. He is the author and course director of the two-day short course “Writing SOP’s for cGMP Compliance,”  offered through the Center for Professional Advancement in association with The Institute for Applied Pharmaceutical Sciences (IACET). His course is recognized by the International Association for Continuing Education and Training (IACET) and the Accreditation Council for Pharmacy Education (ACPE), and by the Society of Manufacturing Engineers (SME) and the American Society for Quality (ASQ).

He holds a Bachelor of Science degree in Business Administration and a Master’s degree in Business Management from Almeda College and University. He has worked on the research and development of new drug products at the University of Iowa, College of Pharmacy.

Mr. Callahan is licensed by the California State Board of Pharmacy as a Manufacturer of Dangerous Drugs, a long-standing member and past president of the Pacific Technology Exchange (PTE), and a member of the International Society of Pharmaceutical Engineers (ISPE).

Qualifications

Over fifty years of “hands on” and management experience in the pharmaceutical and dietary supplement manufacturing industry. Current consultant to the dietary supplement and drug manufacturing industries. Past lecturer on the course, “Tablet Manufacturing for Supervisors and Managers”. Current author and Director of the course, “Writing SOPs for cGMP Compliance”. Both courses offered through the Center for Professional Advancement in association with The Institute for Applied Pharmaceutical Sciences and recognized by the International Association for Continuing Education and Training (IACET).

International lectures given in Denmark, Israel, Puerto Rico, The Netherlands, and domestically throughout the United States.

Professional Experience

President/CEO
GMP Consulting Services, Inc.

President/CEO
Consulting Services, Inc.

President/CEO/Member
Pharmaceutical Consulting Services, LLC

Founded in July 2007, PCS is a full-service consulting firm that specializes in regulatory compliance. PCS has developed highly successful, innovative programs utilizing boilerplate systems that are adapted to meet the needs of its clients. No other consulting company provides this systematic approach to meeting regulatory compliance issues in an ever-changing environment.

Vice President of Operations-Drug Division
Robinson Pharma, Inc.

March 2006 to May 2008
Recruited by the President/CEO to improve FDA compliance to cGMP’s, and to secure drug licensing through the State of California Department of Health Services, Food and Drug Branch. Assigned full control over Tablet and Hard-shell Capsule manufacturing to implement the necessary controls to obtain drug status. Drug License was awarded in December 2006, nine months after my hire.

Director of Operations
NutraMed, Inc.
November 2004 to February 2006

Recruited by the President/CEO as a plan to improve the company’s overall structure including design, marketing, internal structure, staffing, and to meet compliance issues for future regulatory requirements.

Designed a 7500 square foot expansion to the processing area, which required the reorganization of the Receiving, Quarantine, Raw Material Warehouse, and Weighing areas, which were move into a new 12,000 square foot building. Rewrote all Standard Operating Procedures to meet the requirements of drug manufacturing and used the new SOP’s for training all employees.

Brought in new sales through past contacts, which amounted to approximately $5 million projected for the first quarter of 2006. Company’s prior sales were approximately $5 million annually. Continuing to act as a consultant to the President/CEO.

Vice President of Technical and Regulatory Affairs
Ultimate Formulations, Inc., dba Best Formulations, City of Industry, CA
July 1999 to November 2004

I started as Project Manager responsible for creating entire GMP and SOP program to achieve NNFA GMP Certification. Continued to raise the level of compliance to Drug GMP’s to acquire a Drug License and FDA Registration by April of 2001. Completely reorganized the entire company including all documentation and filing of such documents. Implemented training programs and structured departmental organization and initiated efficiency output program.

Responsible for all technical aspects of the operation along with all regulatory standards and the enforcement of such standards. Primary contact for all regulatory agencies, including the FDA, California Health and Human Services (Food and Drug Branch), South Coast Air Quality Management District (AQMD), and Los Angeles Department of Health.

Director of Operations,
Anabolic Laboratories, Inc., Irvine, CA
July 1998 to June 1999

I started as a Senior Research and Development Scientist responsible for reviewing, re-drafting, and approving formulas for drug and dietary supplement products. Initiated SOP revamping program to update SOP’s that had not been revised in more than ten years.

After 4 months at starting position, I received the promotion to Director of Operations and an increase in pay. As Director of Operations, responsibilities included Warehousing (shipping and receiving), Engineering (maintenance), Purchasing, Manufacturing, and Packaging. This position was part of the Executive Management Staff.

President/CEO
InterTech Pharmaceuticals, Inc., Porterville/City of Industry, CA
August 1992 to June 1998

Founder of the company. Started with a very meager $850 to secure a 2500 square foot “start-up” facility. Acquired processing equipment through contacts with owners of new and used equipment companies on “free lease” basis until the company was able to pay for the equipment through revenues.

In 1994, InterTech purchased the assets of Sonergy, Inc., dissolved Sonergy Corporation and added the product line to the existing contract product line. By 1996, sales grew to a multi-million-dollar level poising the company for a profitable sale to concerned firms. In 1997, after several bids were made by different companies, the company was sold to Jeunique International, Inc. Continued to run the company as President until leaving in June of 1998.

Additional Positions
National Vitamin Company, Inc., 1988 to 1992, Director of Operations
ABCO Laboratories, Inc., 1985 to 1988, Plant Manager
VitaTech International, Inc., 1983 to 1985, Plant Manager
Alacer Corporation, 1983 to 1983 Plant Manager
Packaging Corporation of America, 1982 to 1983, Production Supervisor
NION Corporation, 1981 to 1982, Production Planning Manager
Nutrilite Products (Division of AMWAY), 1980 to 1981, Production Supervisor
Stanley Drug Products, Inc., 1978 to 1980, Production Supervisor
Hall Laboratories, Inc., 1978 to 1978, Packaging and Production Supervisor
ICN Pharmaceuticals, Inc., 1973 to 1978, Processor/Compounder

Education
Bachelor of Science in Business Administration,
Almeda College and University, Boise, Idaho – 2003
Master of Business Administration (MBA) in Business Management,
Almeda College and University, Boise, Idaho – 2004
Bachelor of Science in Pharmaceutical Sciences,
University of California at Berkeley – 1987