Services
Howard S Mehler PhD JD & Associates Incorporated, a California Corporation was incorporated in 1987. Howard S Mehler serves as Chief Executive Officer of the Corporation. Among its principal business activities the Corporation engages in chemical consulting activities pertaining to custom chemical analysis, chemical litigation, research and development, and regulatory affairs.
Service Categories
Chemical Analysis
Quality Control Accountability
Environmental chemicals
Pharmaceuticals
Foods
Novel Matrices
For custom chemical analysis projects we design and implement custom analytical protocols deploying state of the art instrumentation, in a manner which conforms with applicable federal, state or professionally mandated Standard Operating Procedures. Mehler & Associates Inc has developed a network of accredited laboratories that subcontract with our Corporation for the performance of chemical analytical procedures in strict adherence to our research protocols and strict quality control criteria. With our supervision and coordination the subcontracting laboratory produces a complete raw data package which we integrate into a Final Analytical Report that is presented to the Client. Mehler & Associates Inc. works with its Clients and subcontractors under express confidentiality provisions when required.
Due to the fact that we subcontract our chemical analyses projects to "boutique" laboratories, we can design and implement our analytical protocols with the widest selection of state of the art technologies. Some of the methods that we have utilized include (but are not limited to):
| A. |
Gas Chromatography, Liquid Chromatography alone or in combination with Mass Spectrometry (GCMS, LCMS); |
| B. |
High Performance Liquid Chromatography (HPLC) |
| C. |
Inductively Coupled Plasma Atomic Emission Spectroscopy or Inductively Coupled Plasma Mass Spectrometry; |
| D. |
Microbiological and Sterility Testing |
| E. |
Nuclear Magnetic Resonance Spectroscopy |
| F. |
Electron Microprobe Analysis |
For generic examples of Analytical Reports produced by Mehler & Associates Inc. please view the Chemical Analysis subsection of our Publications section.
Please contact us for price quotes for your custom chemical analysis projects.
Chemical Litigation
Howard S Mehler PhD JD has served for more than 15 years as a Chemical and Pharmaceutical Expert in civil and criminal litigation throughout the State of California. He has worked with both Plaintiff and Defense Counsel in reviewing case files, developing litigation and settlement strategy, supervising chemical related discovery, coordinating testimony of multiple chemical experts, drafting discovery requests, motions and responses, and rendering trial deposition and expert testimony.
Please contact Howard S Mehler for consultations and information regarding your chemical litigation.
Research and Development
The Corporation provides consulting services relating to research and development of pharmaceutical and other chemical products. Corporate specialties include the design and solution of models by computerized nonlinear estimation of pharmacokinetic and pharmacodynamic parameters of drugs and intermediary metabolites in mammalian systems, and design and implementation of Absorption, Distribution, Metabolism and Excretion Processes in Phase I pharmaceutical studies.
For a representative example of our Research and Development capabilities view our publication on Lactic Acid Metabolism in the Research and Development subsection of our Publications Section.
Please contact us with your questions regarding planned or ongoing research and development projects.
Regulatory Affairs
| 1. |
Interpretation and application of Federal and State Statutes, Federal and State Regulations, Federal and State Agency Guidelines |
| 2. |
Preparation and filing of New Drug Applications, Abbreviated and Supplemental New Drug Applications, Investigational New Drug Applications, Clinical Investigator Brochures and Clinical Trial Protocols |
| 3. |
Preparation of Bioavailability and Bioequivalence Sections of Abbreviated and Supplemental NDA’s. |
|
