Clinical Trials, Drug & Device Development > Regulatory
At Ascon Health our regulatory approach is both strategies & tactical.
We have an accomplished clinical regulatory strategy team. Its team members have developed sound and approvable strategies with regulatory agencies for drug and biologic development.
We offer a team that has :
● Interacted with the FDA and other international regulatory agencies - including Medicines Control Agency
(MCA), and Therapeutic Goods Administration (TGA)
● Taken products from concept to market
● Developed strategies to cut time to market
● Strong understanding of GCP, GLP, GMP and other regulatory requirements