Services

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

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 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

Individually customized healthcare evaluations and recommendations: www.laurakragiemd.com

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

Startup coaching, Advisory Board

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

Expert Witness background information

Case assessments

Due Diligence Assessments

Patent review and expert reports