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Preclinical Safety Assessment and Regulatory Affairs 510(k), IDE, PMA, ISO evaluation, program design, preparation and filing |
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We are a small organization priding ourselves on offering timely, quality, and cost effective services in the pharmaceutical area. We have successfully filed 90 INDs and led twenty-four firms completely through to IND filing and completion of Phase I.
Preclinical Drug Development Development of a TPP (Therapeutic Product Plan) Chemical and Biological Manufacturing Formulation Development Clinical Drug Development Preparation of Investigator Brochures, clinical protocols and clinical trial reports Complete IND/NDA/BLA/CTD Preparation, Review, Filing, and/or Maintenance Complete Project Training and Management Preclinical Biological and Safety Assessment
Degradent, Residual Solvent, and Impurity Evaluation and Qualification
Post Approval/Marketing Support Scientific review of marketing materials |
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Dr. Gad was the originator of the rodent functional observational battery (FOB), and has extensive experience in the areas of behavioral and neurotoxicology, with current GCS experience in study design and conduct, hands-on testing, SOP , protocol and technique development and evaluation, and data analysis. Animal model experience (and publications) in the field of neurotoxicology includes rats, mice, ferrets, primates, and guinea pigs. He continues to be actively involved in adult , juvenile and developmental neurotoxicity evaluation and has published works and provided training on a validated and FDA accepted canine FOB. |
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GCS is experienced and equiped for preclinical, clinical and survey study design and analysis. This experience is supported by numerous publications in the field, and GCS can offer a unique perspective of experience in both statistical analysis/modeling and experimental toxicology. We maintain and are proficient in the use of SAS 8.1 and other statistical software packages. |
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GCS has performed numerous risk assessments and prepared comprehensive reports on them for pharmaceutical, industrial, agricultural and environmental agents, food packaging materials, Proposition 65 filings and medical devices. |
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Dr. Gad is teaching courses in 2009 on the following topics: Drug Development and Non-Clinical Safety Evaluation of Drugs and Biologics, Registration and Biocompatibility Evaluation of Medical Devices and Biomaterials, First-in-Man Clinical Studies for Drugs and Devices, Biologics Safety Evaluation, and Combination Product Safety Evaluation and Registration. We can prepare and teach a modified form of these courses and several other subjects as courses or seminars, on- or off-site, at reasonable rates. Please click here for the course schedules and topic listings. |
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Dr. Gad has extensive experience and has published widely in the area of immunotoxicology as it applies to drugs, devices, personal care products, pesticides and industrial chemicals. He was the originator of the mouse ear swelling test (MEST) in 1984 and further developed variations designed to evaluate photosensitization and cellular immune suppression. He has assisted clients in solving both preclinical and clinical immunotox problems and in designing and interpreting studies to evaluate them. He has also helped industrial groups develop and refine preclinical and clinical sensitization protocols. |
| GCS is extensively experienced in developing and implementing programs to clarify and solve problems/issues around the preclinical, clinical, and manufacturing safety of pharmaceutical products and medical devices, keeping development, production and marketing of drugs on or near plan.
Dr. Gad initiated and managed the occupational toxicology program at Searle, identifying needs, developing data and generating Material Safety Data Sheets for all compounds and process intermediates, making them available worldwide by an electronic system. Airborne control objectives were generated for all production materials, allowing cost effective engineering of safe facilities, compliance with domestic and international regulations, and flexible management of synthesis and manufacturing operations. |
| If GCS does not offer the particular expertise that you require,
perhaps another member of The Roundtable of Toxicology can help:
Particularly recommended are Dr. William Brock (http://www.brocksc.com) and Dr. Robert Kapp (http://www.biotox.net). |