Address:
2233 Argentia Road, Suite 308
Mississauga, ON L5N 2X7
CANADA
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Contact Info:
T: (877) 244-4844
Website URL:
www.ashuren.com/
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Organization:
Ashuren Health Sciences
About Us
Ashuren is a team of experienced professionals, consisting of board-certified toxicologists, regulatory affairs specialists, and scientific writers, with primary offices in the Canada and the United States. Our dedicated consultants have a proven track record of success in the development and registration of biologics and pharmaceuticals. We design comprehensive, tailored development strategies and provide continued support throughout product development.
The team at Ashuren provides unparalleled experience in the management of nonclinical testing programs to ensure correct interpretation, and positioning of reports and data, and in the preparation of superior regulatory strategies and submissions. We strive to meet your timelines and to exceed expectations. Our expertise allows you to achieve your milestones with uninterrupted clinical development.
Products / Services:
Strategic Planning
cost effective development, integrate nonclinical program with clinical development, anticipate and overcome regulatory hurdles.
Program Management
design and assist with pharmacology and toxicology programs from protocol development, CRO selection and placement/monitoring of studies, study audits, preparation of integrated summaries, review of final reports.
Regulatory Affairs
regulatory strategies, preparation of CMC (including biologic/biotech products), nonclinical and clinical summaries and tables, from pre-meeting packages to filing full submissions to conduct clinical trials or market registration world-wide.
Consulting and Expert Advice
assistance in lead candidate selection, due diligence activities, third party assessments, interpretation and positioning of date, liaison with regulatory agencies worldwide and responding to questions.
Other Categories this company can be located in
Healthcare
Research Services
Clinical Research Organizations
Compliance
Regulatory
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