Regulatory Affairs
FDA ORPHAN DESIGNATION – ODD
The BIOPHARMA GLOBAL team offers significant expertise in delivering a successful Orphan Drug designation application. Our team completes the entire application with delivery of a solid first draft in 10 to 15 business days.
EMA ORPHAN DESIGNATION
BIOPHARMA GLOBAL works closely with our clients to determine the best roadmap for a successful EMA application submission. In some cases, a Pre-Submission meeting may increase the likelihood of success but those decisions are reached collaboratively between BIOPHARMA GLOBAL and the client. Similar to the FDA Orphan Designation the BIOPHARMA GLOBAL team constructs the entire application. Our European entity handles all submissions for those clients who do not have their own European based entity.
STRATEGIC REVIEW
A comprehensive review of the epidemiology and therapeutic area in conjunction with the molecular structure. The BIOPHARMA GLOBAL team, working collaboratively with the client, creates a product regulatory strategy and roadmap. This process suggests the feasibility of an orphan designation or some other regulatory pathway.
MEETING REQUEST
BIOPHARMA GLOBAL provides a full spectrum of FDA Type A/B/C meeting services including preparing the meeting request and briefing packages as well as attendance and leading meetings if that is desirable. We also provide a variety of similar services for EU meetings.
BREAKTHROUGH DESIGNATIONS
BIOPHARMA GLOBAL has a very deliberate process for constructing Breakthrough Therapy designations. It starts with a feasibility assessment which when complete informs the client on whether or not a BTD is viable. If the feasibility assessment indicates a positive path forward, then our experts create a roadmap forward taking into consideration their deep knowledge and expertise in working with the various review divisions.
PRIORITY REVIEW VOUCHER
The BIOPHARMA GLOBAL team has vast experience in submitting PRV applications. Our superior epidemiological knowledge and our vast experience in working with the FDA provides our clients a proven roadmap forward and ultimately a successful application and designation.
IND FILINGS
BIOPHARMA GLOBAL’s vast knowledge of the FDA and the expertise which lies within the team gives our clients a distinct advantage when filing an IND. BIOPHARMA GLOBAL’s proprietary program for strategy review, identifying barriers, and then creating a comprehensive maintenance program makes filing an IND a seamless, efficient process.
NDA, BLA & MAA FILINGS
Because BIOPHARMA GLOBAL’s process is an integrated approach with both regulatory advice and a variety of management services we are well equipped to construct marketing applications keeping in mind the various requirements from within the FDA.
