To gain approval for clinical testing after finalizing the pre-clinical testing of innovative new therapies, it is a key milestone for pharmaceutical companies to apply for approval of Investigational New Drug (IND) with FDA or other agencies. With the rich experience of our regulatory team, Creative Biolabs is dedicated to providing regulatory strategy consulting service to facilitate your IND approval.
Since FDA and other regulatory agencies started to implement complicated regulatory systems to control the chemical quality, manufacturing and usage of pharmaceutical drugs, it has become a challenging issue for drug registrations and approvals to be compliant with the stringent regulatory requirements. Hence, Creative Biolabs offers well-defined regulatory strategies during the whole lifecycle management of your products to meet the submission requirements, and guide pre-clinical testing to comply with the mandatory regulatory requirements.
To avoid delay in product registration and reduce the costs, it’s essential to fully understand accurate regulatory strategies for the specific product type. Creative Biolabs is a right partner to help conduct strategic plan and monitor regulatory changes, which is a key for ultimate successful drug approval.
Creative Biolabs is committed to being a preferred regulatory strategic partner for pharmaceutical companies, with a proven track record to keep abreast of current regulatory conditions and guide clients to understand their specific regulatory requirements. Please contact us for more information and a detailed quote.
For lab research only, cannot be used for any clinical use.