Regulatory submissions are complex and can be challenging to get right the first time. At GLOBAL, we know the challenges that come with meeting regulatory requirements. We help our clients and partners find their way through an often confusing and hazy regulatory environment to ensure success. To share some of this expertise, we sat down with Julie Moon, our Director of Business Development and long-standing expert in the regulatory space. We asked her what her top tips were for IND submissions.
Read more about IND submissions here.
It is important to tap into the collective knowledge base of a fractional Regulatory CMC Team, especially if this is your team’s first IND. Many companies come to us in preclinical, and it’s a critical moment. Your first IND is arguably the most important one you’ll ever submit. Beyond the therapeutic and financial stakes, it sets the tone for how the FDA will view you moving forward. Use the FDA’s IND planning tools, and partner with a Reg CMC Team experienced in first-time INDs.
A pre-IND meeting might seem like an added step, but it can actually save time and money and get your product to market faster. It can result in eliminating extraneous planned studies, help prevent significant IND Information Requests (i.e., like ones that require additional studies – time killer!) or a Clinical Hold, and can help provide strategic IND guidance that speeds up review. Even just the act of preparing the pre-IND meeting package can help identify gaps and brainstorm potential strategies.
For particularly complex products, consider an INTERACT meeting (i.e., before your pre-IND meeting) to get concurrence on product attributes like toxicity study design or novel manufacturing methods.
Drafting the IND is more than just technical writing; it takes planning, strategy, and active communication. In early-stage companies, the IND will most likely be written by multiple contributors, most of whom will be juggling multiple roles; this can lead to disjointed messaging. A cross-functional holistic review ensures alignment across sections and clarifies the “story”. Does your manufacturing history section appropriately mirror your manufacturing process section? Do the methods in your batch analysis section correspond with your analytical methods section? Can you defend that your product is truly one drug substance with two intermediates, and not multiple drug substances (which would require multiple 32S3’s)?
GLOBAL is collaborative and flexible, supporting sponsors of all sizes and stages. We integrate quickly with your teams and maintain strong communication. We’ve guided our clients through INTERACTs, pre-IND meetings, Information Requests, and Clinical Holds. Positioned between sponsors and the FDA, we know what works (and what doesn’t).
Trite but true: plan early, engage early. Take advantage of online consortia and FDA guidance. Strongly consider INTERACTs and pre-IND meetings. Bring on a fractional Reg-CMC function as soon as you select your lead candidate and look for a partner who won’t charge a retainer. Many, like GLOBAL, don’t.
Reach out to us to learn how our leading team of experts can help with your regulatory submission today!
For sponsors developing new therapies, one of the most critical milestones on the regulatory pathway is preparing and submitting a New Drug Application (NDA). While biologics require a Biologics License Application (BLA), small-molecule drugs follow the NDA process.
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Whether you’re submitting to the FDA, EMA, or another authority, the CSR must tell a clear, compliant, and credible story of your trial. GLOBAL's Medical Writing team shares tips and tricks to get it right.
