Biosynergetics, Inc.
P. O. Box 5045
Zionsville, Indiana 46077
Phone 317.506.7000
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Biosynergetics, Inc.P. O. Box 5045 |
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The term biosynergetics as used here represents the activity of biotechnology creation through various types of arrangements.
Biosynergetics, Inc. is an independent biomedical and medical research and consulting resource specializing in biomedical engineering, medicine and pharmaceutical science. Applications include industrial, legal, medical, capital financing, university research and intellectual property development. Areas of expertise include pharmacology, internal medicine, medical oncology, nuclear medicine, psychiatry, psychopharmacology, biopharmaceutics and drug disposition. A network of scientists and physicians support these efforts.
The company has particular experience and familiarity within Indiana and is focused on strengthening Indiana’s presence in the biotechnology arena. Contractual work supporting risk-up-front analysis for corporate customers and startups, routine regulatory overflow work, upper level review of biotechnology projects and legal expert opinion drafting funds most of the work to date. Biosynergetics, Inc. also owns patent rights supporting medical devices and is pursuing these entrepreneurial efforts.
Eldon H. Nyhart, Jr., Ph.D.
info@biosynergetics.com
Regulatory
Document preparation, analysis and assessment, and regulatory submission preparation
and review. Preparation and review of IND and NDA submission documents. Correspondence
with the FDA on matters other than standard submission documents. Complete final
clinical study report preparation and submission. Drug package insert preparation
and updating. Review of drug dissolution and correlation analyses, drug dosage-form
design and formulation development data.
Scientific
Development and study of the adequacy of dosing regimens and dosage formulations.
Analysis of drug interactions, toxicity, side effects, population effects, in
vitro data, animal scale-up, small- and large-scale population studies. Design
of clinical trials, analysis of human and animal data, and submission to regulatory
and health organizations. Collaboration to produce protocols and final reports
for Preclinical, Phases I, II, III and IV of drug development. Collection and
analysis procedures for various types of biomedical measurements, biological
sample handling, and analytical assay methodology design and development. Pre-clinical
data evaluation and extrapolation to man, species scale-up, pharmacokinetic,
pharmacodynamic and population data analysis and modeling. Development of pharmacodynamic
and pharmacokinetic data acquisition methods and analytical methodology with
incorporation into clinical protocol designs through clinical database fabrication
sufficient to support data analysis. Pharmacodynamic data analyses, dose-effect,
and dose-response modeling. Pharmacokinetic and statistical data analysis and
evaluation using various mathematical modeling and statistical computer software
packages for submission to the FDA. Radiocarbon study design and analysis, dose
escalation studies, drug-drug interaction studies, mass balance and metabolite
identification and analysis, and large scale multi-center international efficacy
trials.
Legal
Expert witness and legal case preparation. Preparation of professional journal
articles for publication. Due diligence for biotechnology related projects.
Patent development and patent infringement consultation. Medical malpractice
and biotechnology consultation. Venture capital independent scientific assessment.
Scientific education and presentation. Biotechnology business development and
support. Anti-bioterrorism investigation.