Strategic Product Development
Offering decades of strategic development experience, global compliance, and therapeutic experience to ensure your promising therapy isn’t delayed by risk or limited resources.
Opportunities in APACee
Small and mid-size biopharma companies in the U.S. and Europe are under pressure to find more efficient ways to commercialize their products. As a result, sponsors have begun to shift their focus to the Asia-Pacific region for their studies.
IND applications: 4 common mistakes
Before a Phase 1 trial begins, an investigational new drug application must be approved by the FDA. This critical step grants an exemption to laws prohibiting the transportation of drugs across state lines prior to market approval.
Taking your product to the next level
Our consultants work with you to design and implement comprehensive plans to enable successful product development from early discovery through IND and post-approval lifecycle management, supporting the regulatory pathway and tactical implementation.
Premier Thought Leaders
There’s no substitute for experience. And we have a lot of it. See what we’ve been busy doing for the past five years.