Meet our Dynamic Team: Experts Driving Innovation and Success


Our team specializes in linking innovation with regulatory strategy

At, our team is adept at fusing innovation with regulatory CMC strategy. We understand that true innovation requires not just ingenious ideas, but also meticulous compliance with industry regulations. Our team of experts specialize in navigating this complex terrain, seamlessly integrating cutting-edge developments with pertinent regulatory requirements. We strive to deliver solutions that not only push the boundaries of what’s possible, but also maintain a strong foundation in regulatory compliance, ensuring that your business thrives in its respective market. Turn to, where innovation meets regulation, and where your visionary ideas find a path to real-world implementation.


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    What our clients

    say about our team

    Enkrisi’s Regulatory Strategy Team: Highly Skilled and Effective in the Pharmaceutical Industry

    As someone who has worked in the pharmaceutical industry for several years, I can say without hesitation that Enkrisi’s Regulatory strategy team is top-notch. Their team of experts is highly skilled at navigating the complex regulatory landscape, and they are always on top of the latest developments in the industry. I highly recommend their services to anyone looking to bring a new drug to market. Enkrisi’s Regulatory Consultants have a strong history of effective communication. They can author critical messages supported by scientifically-cohesive narratives, reports, and data summaries for your investigational and marketing submission documents.

    Lisa D

    VP, Regulatory Affairs and Quality Assurance

    Enkrisi’s Quality and Expertise Critical to Drug Sponsor Success

    Since transitioning to a drug sponsor role, I have continued to rely on Enkrisi for their guidance and assistance in ensuring our drug product meets regulatory standards and is ready for commercial distribution. Your team’s attention to detail and commitment to quality have been crucial to our success. Enkrisi’s experienced contract regulatory writers can provide Common Technical Document (CTD) content, FDA Briefing Books, meeting minutes, slides, and more to help you meet or beat every deadline, challenge and improve document quality, and become someone you can unquestionably rely on.

    Lynn G

    SVP Regulatory Affairs

    Enkrisi: Top-Tier Drug Development Support for Due Diligence and Licensing Deals

    Enkrisi’s drug development support services are among the best I have ever encountered for due diligence and licensing deals. Their team of experts is highly knowledgeable about all aspects of CMC operations management, and they are always willing to provide guidance and support to help their clients succeed. They are genuinely passionate about what they do and are committed to helping their clients bring new, innovative drugs to market.

    Brian S

    Operating Partner - Life Sciences

    Enkrisi: Exceptional Drug Development Support from Research to Commercial Distribution

    Enkrisi’s drug development support is truly exceptional. From the earliest stages of research to the final phases of clinical trials, their team is there every step of the way, providing guidance and support to help ensure success. Their expertise in CMC operations management is particularly impressive, and they are always willing to go above and beyond to help their clients achieve their goals. If you are developing a pharmaceutical drug product for commercial distribution, seeking expert assistance with CMC regulatory work from Enkrisi can help you manage and lower regulatory risk and avoid regulatory delay.

    Jamie D

    Director of CMC

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