Who We Are
At Leeah Consults LLC, we offer specialized consulting services to clients in the 503B Outsourcing Facility, Pharmaceutical, and Compounding Pharmacy sectors. Our firm is distinguished by a steadfast commitment to patient-focused quality and a rigorous adherence to industry best practices.
Our consulting services offer a broad range of specialized areas, including:
Business Strategy and Company Culture
Drug / Product Development
Formulation Development
Clinical Development and Functions
Quality Systems and Processes
Facility Conceptions
Manufacturing Processes
Controlled Substance Compliance
We help organizations launch new facilities, plan strategically, develop drugs and formulations, navigate regulations, and maintain high product quality to enhance patient outcomes. Our consulting focuses on evidence-based quality processes, including continuous monitoring and thorough investigations, ensuring products meet the highest standards with patients as our priority.
Our founder, Travis Leeah, brings over 25 years of experience in sterile compounding and 33 years in pharmacy practice. Throughout his distinguished career in the compounding and outsourcing sector, Mr. Leeah has held a range of leadership positions including Owner, CEO, President, COO, Pharmacist-In-Charge, and Vice President. Notably, he guided Unique Pharmaceuticals through comprehensive remediation and achieved full compliance with FDA 503B cGMP standards, securing third-party sterility assurance certification for the facility. Mr. Leeah implemented one of the first compounding laboratories with an integrated quality system and pioneered advanced endotoxin and sterility testing methods for compounded sterile preparations.
He has contributed his expertise on two Texas State Board of Pharmacy Compounding Committees, advocating for quality-focused regulations within the industry. He has been a public speaker on multiple topics within the compounding and drug development industry. As an expert in drug development, Mr. Leeah has formulated enhanced stability solutions for sterile products, suspensions, topical ointments, and gels, as well as developed innovative stabilizers and buffers that improve the stability of sensitive drugs. He holds multiple patents for his discovered drug formulations.
Mr. Leeah earned his Pharmacy Degree from the University of Texas College of Pharmacy, MBA from Baylor University, and is Board Certified in Compounding Sterile Preparations Pharmacy from the Board of Pharmacy Specialties.
Experience
Summary:
Mr. Leeah is an experienced leader in the Pharmacy Compounding Industry with over 25 years’ experience. From an executive level, he has held positions of Owner, CEO, President, Vice President, and various other positions in the compounding industry. Mr. Leeah has led clinical pharmacy functions, research and development, and various regulatory functions that pertain to FDA, State Board of Pharmacy, and DEA regulations. He has subject matter expertise in Research and Development, creating new drug formulations from a knowledge of Medicinal Chemistry, Pharmaceutics, Clinical Pharmacy, and Current Good Manufacturing Practices (CGMP). Mr. Leeah has a unique skill in applying Clinical and patient impact with chemical development to various drug formulations and changes in drug formulations. He is experienced in writing many differing drug formulations and is an inventor of several drug formulation patents. Mr. Leeah is experienced in overall industry strategy at the executive level of 503B outsourcing facilities and has owned a 503B outsourcing facility and overhauled a compounding pharmacy to completely meet all 503B GMP requirements, including receiving a letter from FDA stating such.
Past Experience:
Member of the planning committee to set agenda and speakers for the FDA Compounding Quality Center of Excellence 2025
Served on the Texas State Board of Pharmacy Task Force on Pharmacy Compounding in 2005 and 2013
Grew and expanded a compounding facility that produces 12-15 million dollars in sales per year.
25 years’ experience in formulation development and R&D of sterile parenteral products (have formulated approximately 300 drug formulations.
Hold patents in various drug formulations:
Ropivacaine, Epinephrine, Clonidine, Ketorolac (RECK) patent/10952963
Buffered Lidocaine with Epinephrine patent/10952962, and 10952962B1
Lidocaine, Epinephrine, Tetracaine (LET) solution/gel, patent 17/685,792
Vasopressin injection formulation patent expired
Implemented a quality lab testing department for compounded medications (testing in-process, end-product, and raw material verification).
Implemented an overhaul of a compounding pharmacy to meet the 503B Outsourcing GMP’s and received letter of approval from FDA.
10+ years’ experience in 503B GMP’s.
Developed state-of-the-art compounding processes through LEAN engineering
Implemented a quality management system within a compounding pharmacy
Successful in achieving the first ISO 9002 certification (and later ISO 9001:2008) for a compounding pharmacy within the USA.
Vast experience in DEA manufacturing regulations
Vast experience in sterile processes and compounding sterile suspensions
Implemented a sales team that focuses on the primary hospital compounding outsourcing market
Experienced public speaker in many speaking engagements in all compounding topics, USP chapters, regulations, quality systems, and testifying on legislative bills
Certified in Compounding Techniques, Sterile Compounding, Veterinary Compounding, and Internal Auditing of Quality Management Systems
