REGULATORY CONSULTANTS:

HERSCHEL J. GADDY & ASSOCIATES

PROFESSIONAL ACCOMPLISHMENTS

• Provided leadership to guide a number of troubled human and animal health pharmaceutical manufacturers to current GMP (cGMP) compliance.
• Expedited approval of fermentation and organic synthesis types of supplier Drug Master Files (DMFs) and Veterinary Master Files (VMFs) with FDA.
• Developed Independent Contractor and Animal Testing Laboratory DMFs and VMFs and obtained approvals with FDA.
• Engineered over 100 New Drug Application (NDA) and New Animal Drug Application (NADA) approvals which consisted of NAS/NRC DESI NADAs, full NDAs/NADAs and abbreviated NDAs/NADAs (ANDAs/ANADAs) for pharmaceutical dosage forms and medicated premixes/complete feeds.
• Generated over 1,000 Supplemental NDA/NADA (SNDA/SNADA) approvals, including alternate raw material active pharmaceutical ingredient (API) sources, improved processing procedures, enhancement of raw material, packaging material and finished product specifications, improved instrumental and microbiological analytical methodologies, validation of analytical methodologies and alternate manufacturing sites.
• Obtained regulatory approval for numerous animal drug products for marketing in Asia, Canada, Europe, Mexico and South America.
• Obtained approval of DMFs and VMFs for primary and alternate site manufacturing facilities, which included filter validation, container closure, integrity testing, environmental monitoring, antimicrobial preservative effectiveness (APE) testing and all other aspects of aseptic process validation.
• Integrated funtionalities and directed compliance activities of Manufacturing, Quality Assurance/Quality Control (QA/QC) and FDA Regulatory Affairs Departments in order to establish cGMPs in the 1990s at animal health medicated premix/complete feed and human and animal health pharmaceutical dosage form manufacturers.
• Developed QA/QC and Operational Standard Operating Procedure (SOP) infrastructures for start-up human and animal health pharmaceutical manufacturers and Schedule II, III, IV & V Drug Enforcement Agency (DEA) Distributors.
• Networked to develop a team of Employees and Associates that represent QA/QC Analytical Chemistry, Human Resource, Manufacturing, DEA, EPA and FDA Regulatory Affairs and Veterinary Medicine disciplines with an accumulation of over 200 man years of experience, which includes 26 years of ever-increasing levels of responsibility and prior service for an Associate on-staff at the Center of Veterinary Medicine (CVM).

SUMMARY

• Your company will receive resourceful, efficient and confidential consultation in problem solving, formulation and process development, aseptic and non-sterile process validation, clean-out validation, calibration of instruments, gauges and devices, installation and operational qualification protocol development, procedural guidance via development of SOPs, cGMP audit service, compliance strategy development and training, QA/QC issues and assembly, filing and follow-up services with FDA on DMFs/VMFs, ANDAs/ANADAs, NDAs/NADAs and SNDAs/SNADAs: along with liaison services for outsourcing analytical method development, analytical method validation, contract research, contract synthesis, contract manufacturing facilities and related support activities.

GOALS AND OBJECTIVES

• To develop economically viable independent contractor consulting and business relationships with DEA, EPA and FDA regulated clients.
• To offer a cost-effective, results-oriented approach to problem solving, cGMP compliance, manufacturing site transfers, product development and DEA, EPA and FDA regulatory affairs.
• To provide DMF, VMF and exclusive USA Agency application, approval and maintenance services.
• To derive mutual client and contractor benefits from a proactive approach to the contemporary, ever-increasing, scientific and regulatory requirements established by DEA, EPA and FDA.
• To provide Quality Audit and cGMP training for current and new clients.
• To provide competent and confidential third party business development services for our clients.
• To take great pride in our work and our ability to communicate effectively with others and perform assigned tasks in a timely manner for our client.

W. Gregg Croner, BA	Pharmaceutical Manufacturing Technology and GMP Training Associate
Donald A. Gable, DVM	Senior FDA Regulatory Affairs Associate
Herschel J. Gaddy, Ph.D.	Principal FDA Regulatory Affairs and Pharmaceutical Technology Consultant
Kip L. Kjellesvig	Pharmaceutical Manufacturing Technology and Quality Assurance Associate
Duane K. McCombs	Professional and Executive Recruiting Consultant
Roger A. Rohrer, MS	Analytical Laboratory and Pharmaceutical Manufacturing Quality Assurance Associate
C. Michael Schofield, MA	Environmental Research Consultant
Caroline M. Schellpeper, BS	Quality Assurance Technology Development and GMP Training Associate
Richard M. Schwarz, Ph.D.	Analytical Laboratory Technology and Synthesis Development Associate

Please contact us anytime! WE CAN HELP!

Toll free phone #: 877-GDL-8700/877-435-8700 within the USA
Phone #: 816-364-3520 outside the USA
Toll free fax #: 866-GDL-8700/866-435-8700 within the USA
Fax #: 816-364-0764 outside the USA
E-mail: marcygdl@aol.com

Address: 3715 Beck Road, Building C, Suite 307
St. Joseph, Missouri 64506