Kragie
BioMedWorks (R) 

SERVICES AVAILABLE

Specialized / Integrated Medical Writing

Newsletter articles; ebooks; online media
Vetting nonfiction and fiction material for scientific and medical authenticity
Blogging: healthcare delivery models, impact of discoveries, integrative health insights
Science and Medical publications arising from preclinical and clinical studies
Grant writing assistance: government, nonprofit and for profit enterprises
Reports on research breakthroughs in biotechnology
Fiction Books: Publishing services provided under the subsidiary, TriplePlay Publishing (tm) LLC

Areas of focus / Niche services

Hormonal influence on drug metabolism and effect
Drug-thyroid hormone membrane transporters
Aromatase Assay to screen reproductive toxicity
Assessment of potential endocrine disrupters
Reproductive and pediatric labeling sections of Package Inserts
Speciality Areas: aromatase, estrogen, thyroid hormone, ADHD safety issues

Drug Formulation Development

Drug Delivery Optimization and Enhancement
Novel routes of administration for established therapies and indications
Design of efficient pharmacodynamic parameters/biomarkers for formulation testing
Drug registration strategies for franchise extension related to new formulations

Clinical / Medical

Individually customized healthcare evaluations and recommendations
Preclinical Assessment and development of biological surrogates markers
First in Man studies: when and how to do
Clinical Trials: design, data analysis and report writing, Phase I - IV
Adverse Event: interpretation and investigation
New Drugs: indications, dosing, drug labeling (Package Insert)
NDA/IND applications: planning / writing / review
Investigating unmet clinical needs: new indications for approved drugs
505(b)2  NDA strategies

Drug Development / Business Intelligence

Portfolio development and pipeline strategies
Technology transfer activities in biotechnology
Venture capital project assessment: evaluation of biotechnology intellectual property and FDA regulatory strategies
Drug Development strategies: preclinical through postmarketing phases
White Paper reports on market niches, estimate trends

Legal Assistance

Expert Witness background information
Case assessments
Due Diligence Assessments
Patent review and expert reports


Last modified on March 03 2013
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