Ashuren Health Sciences core strength lies in providing innovative solutions to complex development as well as scientific & regulatory issues. Our toxicologists and regulatory scientists can complement your team by providing services in the following areas:

• 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.