Regulatory Strategy Consulting

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.

Regulatory Strategy Consulting Services

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.

Capabilities

• ✔ Strategic planning for IND enabling studies during development of a product.
• ✔ Strategic planning for various agencies across the globe such as FDA, CFDA, EMA, etc.
• ✔ Identification of reference medicinal product based on the Global Commercialization Plan and defining the regulatory roadmap.
• ✔ Both paper format and electronic Common Technical Document (eCTD) submission available.
• ✔ Specialized in current therapeutic pharmaceutical regulations.

Regulatory Consultation for IND Services

• ✔ Medical writing and translation for IND dossier
• ✔ Pre-IND dossier package requirements
• ✔ Pre-IND meeting
• ✔ IND package publishing
• ✔ IND package submission
• ✔ Post-IND services and response to HA queries

Highlights

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.

• ✔ A comprehensive understanding of regulatory guidelines and updates;
• ✔ Road map for the products already registered with one HA to register with another HA to enhance business;
• ✔ Post-approval submission strategies for the proposed changes to maintain the compliance and to submit supplements, variations, amendment to minimize the manufacturing and regulatory cost to client and obtain approval faster.

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.