Chemistry
Manufacturing & Controls
Navigating Regulatory CMC Success: Expert Services for Drug Development and Commercialization
The company also oversees contract services, including CMOs, and specializes in designing and upgrading manufacturing processes for small molecules, biologics, and biosimilars. The goal is to help clients develop and approve their products successfully.
How we can help
How we can help
CMC DEVELOPMENT
What makes Enkrisi your ideal choice?
One of our key areas of expertise is designing, implementing, and upgrading manufacturing processes for a range of products, including small molecules, biologics, and biosimilars. This includes advising on the most appropriate manufacturing processes, ensuring that quality systems are in place, and providing guidance on the regulatory requirements for manufacturing facilities.
Overall, our CMC development consulting services offer valuable support for clients navigating the complex development and manufacturing process for pharmaceutical drugs and biologics. Our expertise in formulation development, process and analytical development, validation, and quality-based manufacturing and analytical method development, combined with your regulatory support, quality assurance, and compliance services, can help clients achieve successful outcomes in developing and approving their products.
Your success,
stories
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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