Anna Metcalfe, RAC

V.P. Regulatory Affairs

Ashuren Health Sciences (a division of Cantox Health Sciences International)
2233 Argentia Road, Suite 308
Mississauga, ON,
Canada, L5N 2X7
Phone: (905) 542-2900 Ext. 265
Fax: (905) 542-1011
Email: ametcalfe@ashuren.com
Web: www.ashuren.com

Ashuren Health Sciences is a team of experienced professionals with diverse and in-depth experience in scientific and regulatory consultancy. Our integrated team consists of board-certified toxicologists, regulatory affairs specialists and scientific writers. Our resource and innovative staff provide responsive and cost effective services, preventing unnecessary delays or repeating studies in the development of your product, whether this is a pharmaceutical, biotech, natural health, medical devices, veterinary, combination, or cosmetic & personal care product. We provide:

Toxicology Consulting: integrate nonclinical program with clinical development, program management for design of pharmacology and toxicology programs from protocol development, CRO selection and placement/monitoring of studies, study audits, preparation of integrated summaries, and review of final reports.
Regulatory Affairs: comprehensive regulatory strategies, preparation and review of submissions, scientific writing of nonclinical, clinical and CMC data, and filing submissions for pre-meetings, INDs/CTAs or market registration world-wide, facilitate interaction with regulatory agencies and issue resolution.
Product Development: assistance in lead candidate selection, due diligence activities, interpretation and positioning of data on human starting dose and clinical trial design, assessment of first-in-human protocols.
GLP Monitoring and Compliance: Audits and inspections, development of compliance programs to meet FDA, OECD and other international requirements.

We succeed when our clients succeed and we have proven this time and time again!