Successfully Navigating your Path to Regulatory Approval

Connecting Innovation with Regulatory Strategy

Enkrisi is a full-service regulatory and product development consulting firm for biologics, pharmaceuticals, and medical devices. Created over the past 20 years but launched in 2023, Enkrisi has become the go-to consulting partner for companies large and small seeking to bring innovative, safe, and effective products to market within the U.S.

Enkrisi was founded on the premise that biotechnology, medical devices, and pharmaceuticals promise a better future for everyone. Making good on that promise requires innovative approaches, world-class science, regulatory know-how, and a team dedicated to bringing all of it together.

OUR COMMITMENT

Provide capable and dynamic hybrid consultancy services, leveraging our impressively experienced team in drug development regulatory affairs within the life sciences industry. Our purpose is to help you navigate new products from discovery through testing, clinical trials, regulatory approvals and eventual arrival to the market in a streamlined and efficient manner

OUR IMPACT

Regulatory Intelligence is essential for all organizations to stay ahead of the ever-changing regulatory landscape. A modernized approach to regulatory affairs and the development of new technologies and tools for monitoring emerging requirements can help maximize efficiency, reduce licensing timelines, and ensure the accuracy of product details. By investing in advanced regulatory intelligence systems, companies can stay current with impending regulations and remain competitive in their respective industries.

OUR INNOVATION

Our Reimagining Regulatory Pathways Services can help you design and implement best practices to streamline your operations and ensure you stay in line with current legislation. We provide various services covering technical and strategic aspects of regulatory drug development. Our team can help set up an overall strategy that will cover all potential risks while still meeting your objectives. We offer support throughout the entire process, from strategy formulation to implementing and monitoring your compliance plan.

We help you with

Regulatory Affairs

Enkrisi provides regulatory strategy and due diligence services for various products, including devices, biosimilars, and combination products, and offers guidance on Orphan Drugs Designation, Fast Track, Break-through Therapy, Accelerated Approval, ANDA, and 505(b)(2) submissions. They also assist with M&A due diligence assessments and provide FDA meeting preparation, FDA submissions, and engagement consulting services, helping clients navigate the complex regulatory landscape for successful product development and commercialization.

Chemistry Manufacturing and Controls

Enkrisi offers CMC development consulting services for pharmaceutical drugs and biologics, providing comprehensive support such as formulation, process, and analytical development, regulatory compliance, and oversight for contract services. Their goal is to help clients achieve successful outcomes in developing and approving their products by designing and upgrading manufacturing processes for small molecules, biologics, and biosimilars.

Quality Assurance

Enkrisi’s QA services include audits, gap assessments, and management of GMP/compliance situations, covering areas such as vendor qualification, inspections, and data audit services to ensure regulatory compliance, to provide clients with recommendations for improvement and support for regulatory inspections.

Program Management

Enkrisi provides comprehensive project management services with knowledgeable FDA regulation expertise, aiding clients in navigating the regulatory landscape and achieving project success. They also offer Staff Augmentation and Training services to provide access to a full roster of development consultants and regulatory training to help clients ensure their teams are knowledgeable and prepared.

Our approach

We’re constantly striving for better solutions. Our business processes are efficient and transparent so you can see how we perform at every stage of your project.

01
REGULATORY & PRODUCT DEVELOPMENT CONSULTING

Enkrisi is a full-service regulatory and product development consulting firm for biologics, pharmaceuticals, and medical devices. Created over the past 20 years but launched in 2023, Enkrisi has become the go-to consulting partner for companies large and small seeking to bring innovative, safe, and effective products to market within the U.S.

Enkrisi was founded on the premise that biotechnology, medical devices, and pharmaceuticals promise a better future for everyone. Making good on that promise requires innovative approaches, world-class science, regulatory know-how, and a team dedicated to bringing all of it together.
02
How We Work

Get ready to experience the ultimate success! Our team of seasoned industry consultants and hybrid professional services are the driving force behind our clients’ continuous victories. Our Deeper Department comprises subject-matter experts with decades of experience in the industry and/or FDA, giving us an unbeatable “insider” perspective.
We’re not just another ordinary consulting firm. We pride ourselves on delivering cutting-edge solutions and extraordinary results to clients worldwide. We bring unmatched care and commitment to every single client engagement, and that’s why we consistently achieve phenomenal outcomes. So get ready to join our winning team and experience unparalleled success!
03
EXPERIENCE

At every stage of your journey, we’ve got you covered with our top-notch services. We understand the intricacies of the regulatory pathway like no other, and our track record of success is proof of our expertise. Let us give you the edge you need to easily navigate this complex landscape. With our help, you can confidently overcome any challenge and achieve your goals.

REAL-WORLD REGULATORY PHARMACEUTICAL DEVELOPMENT KNOWLEDGE

Get ready to revolutionize your pharmaceutical product development process! Enkrisi brings a wealth of global, real-world experience to the table. Our team of top-notch consultants has decades of experience in every stage of the pharmaceutical regulatory and product development process, and we’re here to help you achieve success.
04
EVERY STEP OF THE PROCESS

We don’t just provide services – we bring innovative approaches, world-class science, regulatory know-how, and a dedicated team. Our goal is to deliver pharmaceutical product development solutions that positively impact public health and improve the quality of life for patients.

With Enkrisi, you’ll receive impactful solutions at every stage of your product’s lifecycle. We’ll guide you through preclinical planning, manufacturing, design, and evaluation of clinical development and to commercialization. We aim to help you achieve commercial success and revolutionize the pharmaceutical industry.

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

Join our team

In a world of rapid innovation, we seek New Pioneers and Brave Inventors who want to impact all aspects of our business, enabling breakthroughs that will affect future generations.

We encourage you to bring your disruptive thinking, collaborative spirit, and diverse perspective to our organization. We will continue Inventing for Life, Impacting Lives while Inspiring Your Career Growth.