Elizabeth Moyer Email and Phone Number

M/P Biomedical Consultants LLC provides biotechnology and pharmaceutical companies with advice and services required to initiate clinical trials and to obtain market approval for drugs and biologics. We supplement our own expertise and experience through a network of colleagues in industry and university and with a carefully chosen array of highly qualified consultants and audited contract facilities.Services• Evaluate client's preclinical research and development plans and facilities and review R&D accomplishments. Provide advice on basic research, product development, contract laboratory and manufacture options.• Coordinate in-house research efforts and contract preclinical testing, pharmacology and toxicology studies to most efficiently foster product development. Assist in recruitment of product development, clinical and regulatory staff.• Design and supervise studies using most appropriate preclinical models to test the efficacy, safety, absorption, distribution and metabolism of drugs and biologics. Identify and evaluate contract facilities and manage contracts for efficacy and safety testing (pharmacology, GLP toxicology), as well as for lot-release product testing.• Identify and evaluate contract facilities and manage contracts for GMP drug and biologics manufacturing, fill and finishing facilities. Assist in setting specifications, batch record and SOP writing.• Identify and manage contract facilities for development pharmaceutics and analytical method development and validation, including bioassays.• Provide advice and assistance in preparing regulatory submissions and initiating clinical trials. Generate pre-IND and IND packages. Assist clients to prepare for, and then accompany them to, meetings with regulatory agencies. Collaborate in the preparation of marketing applications.• Conduct audits of clinical study reports.Specialties: Integrative approach to pharmaceutical development, with experience and skills in nonclinical, CMC, clinical and regulatory affairs aspects of drug development.