The term biosynergetics as used here represents the activity of biotechnology synthesis and integration through various types of arrangements. We have extensive experience in the pharmaceutical industry, including clinical trial design and monitoring, the evaluation of drug delivery, toxicity, and adverse drug events. Our areas of expertise include pharmacology, biopharmaceutics, drug disposition with particular expertice in the areas of absorption, distribution, metabolism, elimination and effects associated with chemical entities in biological systems, as well as applied clinical pharmacology and industrial pharmaceutics. Emphasis includes pharmaceutical science and biomedical engineering consulting with extensive experience for all manner of compound manufacture, investigation, modeling, dosage-form design, and drug effects.
Scientific document preparation analysis have included regulatory submissions, clinical trials, human and animal data, compound interaction, toxicity, side effects, population effects, in-vitro in-vivo data, animal scale-up, small and large scale population studies, pharmacokinetics, pharmacodynamics, biopharmaceutics, clinical pharmacology, industrial pharmaceutics and biomedicine. The scientific and medical writing support involve documents such as grant applications, patents, transcripts, independent technical assessments, legal documents, protocols, and regulatory submissions.
We provide intellectual property development for US and OUS patents, with several patents awarded in the US and OUS, with several additional US and OUS patent applications pending within Biosynergetics, Inc.
We provide litigation support, case screening, various aspects of discovery, and deposition preparation. We provide evaluation of proposed complaints and regulatory compliance issues, which have included FDA and global document preparation and submission. We prepeare a comprehensive report, which includes problem identification and review, key point assessment, conclusions and recommendations.