Reimagine Your Regulatory CMC Program with Expertise and AI Excellence


Introducing ENKRISI – the leading consulting group helping organizations comply with drug regulations through a comprehensive drug development model incorporating augmented Intelligence (A.I.) and data analytics. Our Reimagining Regulatory Pathways Services can assist you in designing and implementing best practices to streamline operations and ensure compliance with current legislation.


Introducing ENKRISI – the leading consulting group helping organizations comply with drug regulations through a comprehensive drug development model incorporating augmented Intelligence (A.I.) and data analytics. Our Reimagining Regulatory Pathways Services can assist you in designing and implementing best practices to streamline operations and ensure compliance with current legislation.

We’re more than a team of experts, we’re your partners

This Consulting firm is investing now to build new models and technology that allow us to offer promising AI-based solutions. An example of how disruptive AI can be to the industry is the introduction of Robo-advisors. Financial consultants providing asset management services are witnessing their functions quickly become automated. (Think Regulatory Robo Advisors)

The firms that incorporate AI into consulting projects and train consultants to utilize that technology (or offer the technology directly to the sponsor client) will gain a competitive advantage in the AI age. The firms preparing to bridge the AI-based tools created by tech firms and the real strategic challenges faced by prospective clients are also likely to find themselves a sustainable niche in the new business environment. 

Discover our AI-based tools

EnkrisiGPT Logo with Tag


EnkrisiGPT enhances decision-making and action-taking by efficiently processing massive amounts of data for sponsors and regulatory scientists, providing actionable strategies

Navigating the New Regulatory Normal

Who do we serve?

Our services cater to start-up biotech and/or emerging pharma companies, established pharmaceutical companies, academic institutions, CMO/CROs, and venture capitalists looking for innovative solutions and support in the life sciences industry.

Start-up Biotech and/or Emerging Pharma
Our company offers a comprehensive service to emerging biotech companies to help them navigate the complex world of product development, including establishing a concise CMC development and regulatory strategy and plan. We understand the challenges of developing a product and taking over contractors while trying to keep spending to a minimum until certain clinical milestones are met. We can help you make informed decisions, identify associated risks, and develop a plan to mitigate those risks. Our team of experts can help you with everything from clinical trial management to approaching regulatory agencies, ensuring you have the best package possible to achieve success.
Pharma Companies
Enkrisi offers a service for established pharma companies developing a mature clinical target or considering in-licensing a product with phase 2 or 3 clinical data but lacking CMC development data. Our team addresses these issues promptly and evaluates what needs to be done to fill the gaps while considering all costs and risks. We help clients determine whether the project is worth pursuing, which regulatory discussions will be necessary, and build the Quality Modules of the marketing application. Leveraging data, apps, and platforms with Augmented Intelligence (AI), we provide expert guidance and ensure your drugs are optimized for success in the life sciences industry.
Academic Research Institutions
We offer regulatory consulting services to help emerging companies that have developed products out of academia navigate the complex world of regulatory requirements. Our team of experts can help these companies develop a viable and effective chemistry, manufacturing, and controls (CMC) regulatory compliance strategy that meets regulatory standards, reduces risks, and improves patient safety. We can also guide you on securing funding and intellectual property rights, collaborating with industry partners, and navigating the regulatory landscape to bring academic discoveries to market. With our services, emerging companies can focus on clinical development strategies while we handle the regulatory compliance aspect of their product development.
CMOs, or Contract Manufacturing Organizations, are third-party companies that provide manufacturing services for pharmaceutical and biotech companies. They specialize in producing drugs and biologics, offering a range of services from development and formulation to clinical trial and commercial production. Enkrisi offers support by providing cost-effective and efficient manufacturing oversight, offering services from development and formulation support. Our team of industry experts can assist established CMOs, and their emerging biotech customers in understanding and staying on top of rapidly changing regulatory requirements. We help design and implement best practices to streamline operations and ensure compliance with current legislation, whether you need help with technical or strategic aspects of regulatory drug development. We can assist you in developing an overall strategy that accounts for all potential risks while still meeting your objectives, making the complex world of compliance more manageable than ever.
Venture Capital
Enkrisi is a service that provides comprehensive due diligence activities to assist in the in/out licensing of pharmaceuticals for commercialization. This involves a detailed investigation of the CMC information to ensure the technical and quality elements are met for successful drug product commercialization. Enkrisi also advises organizations on CMC aspects of regulatory submissions, development and implementation of CMC regulatory strategy, and identifying and assessing regulatory risks, based on strategic CMC regulatory expectations and government agencies’ regulations on medicines. This service particularly benefits VCs in younger established Pharma and smaller emerging Biotech companies involved in reviewing development data expectations.


Your success,

our pride

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

The latest in biotech for your ears

The VirtualPharm Podcast is an audio series that covers topics related to compliance and regulatory affairs in the Lifesciences industry. Each episode, hosted by an expert in the topic with decades of experience, offers listeners detailed insight into the changing regulatory environment.

The latest in biotech for your eyes

The PathFinder focuses on relevant topics such as regulatory developments, compliance trends, legal updates, enforcement actions, industry insights, and best practices. Articles are written by experts in the field to ensure accuracy and help sponsor companies stay informed about changes in their regulatory environment.

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