PharmaAnalytic was founded in 2009 providing internationally recognized and award-winning experience to advance quality state-of-the-art pharmaceutical product development and promote regulatory compliant and business effective quality management systems.
Principle consultant and founder, Larry Stevens, has over 40 years of pharmaceutical experience extending from Quality, Manufacturing to Research & Development. Experience encompasses large and small pharma, 503(b), Biotech to Fortune 100 companies. Capacities have included Principal Scientist, Directors of R&D, Quality, Quality Control, Quality Assurance, and V.P of Quality. Products types include a wide range of new novel and generic products that span both sterile and non-sterile (e.g., controlled release, injectables, implantable devices, inhalation, diagnostic devices, ophthalmics, solutions, emulsions, liposomes, tablets, capsules, creams, biologicals, consumer products). Material experience spans small and large molecules, radiochemicals, and “smart” materials (e.g., complexes, isotopes, polymers, proteins, peptides, enzymes, phase transition materials, smart gels, gases). Additional experience includes the development and deployment of novel technologies, instrumental systems, and accompanying software.
PharmaAnalytic has a strong analytical approach to the development of novel product systems having unique physicochemical and biological delivery requirements. This has been demonstrated through the development and support of numerous novel products. This includes FDA approved bioequivalent drug delivery products developed from concept through to their regulatory Chemistry Manufacturing and Control (CMC) submissions.
Regulatory compliant and efficient laboratories have been established through either their creation or through remediation. Success has been demonstrated through audits and by review of regulatory bodies. These have been essential in the support of quality systems, CMC submissions, stability studies, products and in the development and validations of hundreds of methods. Additionally, the creation of polymer, materials characterization and research laboratory groups have provided unique, vital and efficient support for the development of unique and successful products.
Some of this work lead to being awarded the Alcon Laboratory Research Award, to international recognition (publishing, speaking, chairing conferences), and was the feature of the Second Annual United States Pharmacopeia Research Consortium.
PharmaAnalytic specializes in the following.
- Quality Systems, Departments & Laboratory Remediation
- Regulatory Compliance and Inspection Readiness
- Novel and Strategic Drug Delivery Product Development
- Innovative Methods Development Supporting Novel Applications
- Validations
- Project Management for Complex Pharmaceutical Systems
- Regulatory and Specialized Training
