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Our services include: 

  • Toxicology/pharmacology strategy and study design, CRO placement, protocol review, analytical method establishment, study monitoring and final report review.
  • Product design and development consultation including formulation review, analytical method development, stability program design, package selection and manufacturing placement and monitoring support,
  • Documentation preparation including IND/NDA/CTD/PMA/510k submissions,
  • Consultation on pharmaceutical, toxicology and medical device research and development program administration and management,
  • Preparation of product safety dossiers, material safety data sheets (MSDS) and product / raw material safety review,
  • Environmental assessments and impact reports,
  • Consultation on safe and efficient research, development, testing and manufacturing facility design,
  • Expert testimony and litigation support for pharmaceutical, chemical and nanomaterial safety cases and issues.

Areas of technical expertise include small molecule, peptide and proteomic pharmaceuticals (including nanotechnology and drug/device products) particularly those designed for topical, oral, ocular administration to aging or other special populations, medical devices that are in vitro diagnostics or are intended for wound healing or tissue repair, orphan drug products, formulation design, review and refinement, environmental assessments, manufacturer selection, inspection and initial production, research and development program administration support and reviews.

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LoneStar PharmTox LLC 2011