Each year, healthcare, pharmaceutical, and biotechnology executives attend the JP Morgan Healthcare Conference, some to tout recent developments, others just to bounce from session to session. We work hard at DSI to make life science companies better at what you do in the Chemistry, Manufacturing and Controls (CMC) areas. We’ve learned that early-stage companies need seasoned expertise to lead their product development forward, and mature companies need practical expertise to retain the agility that drives innovation.
Startups need a solid integrated development strategy, coupled with a credible plan (and budget!) to raise capital, whether it’s the first or fourth round. We strive to bring a collaborative and creative approach to your regulatory, CMC and quality efforts, so together we can bring life-changing products to patients as soon as possible. The products in development today are increasingly complex and demand a partner as ambitious and committed to success as you are. Our regulatory expertise in CMC can be a key element to your development programs.
Due diligence is undertaken to explore a potential deal driven by one company's need for another's product, or in some cases, the other company in its entirety. A detailed investigation of the chemistry, manufacturing, and controls (CMC) information associated with a drug product serves to assure that an adequate level of quality exists for the given compound to allow for successful commercialization of the drug.
A scientific review of the pertinent development data provides the necessary information to assure that informed decisions are made regarding the potential in-licensing of a development compound. By highlighting perceived risks and resource implications, the examination provides assurance that a given compound meets the requisite technical and quality elements.
When weaknesses are addressed before a potential buyer comes in to perform due diligence, the value of the company can be much greater. While due diligence is typically completed by the buyer, it’s become more common for sponsors to conduct their own diligence review to determine any potential gaps within their programs.
My team and I will be available throughout the week to brainstorm your next milestone and help you get there.
DSI is a full-service regulatory drug development consulting firm for pharmaceuticals, biologics and new drug and delivery platforms. DSI provides regulatory, technical, and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and next generation therapy products.
Since 2007 we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence.
Whether advocating CMC strategy, directing CMC operations or developing CMC submission content that represent the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.
Head of Business Development and Marketing
Design Space InPharmatics, llc. (DSI)
Tel: (855) 805-8402×104