We’re the most valuable ally in your path to regulatory success.


Navigating early-stage drug development challenges

You are an emerging Biotech company have just begun the development of a compound or in-licensed a product and received funding. Now the fun starts as you sort through what development has been done, how to cope with establishing or taking over various contractors who have parts of the project and get a clinical trial started or keep one going all this while trying to cope with coming up with a concise CMC development and regulatory strategy and plan as well as a budget for your Board of Directors throughout out-licensing. As you dig in and get going, you realize that the company wants to keep spending to a minimum until certain clinical milestones are met. So what you would like to accomplish and what will be funded are not the same. So how do you handle the product development, what drives the decision to do or to delay, what risks are associated, how do you mitigate those or lobby for support, when do you approach the regulatory agencies, and how do you do it with the best package possible?

We assist start-ups in overcoming these obstacles.

Our CMC regulatory service offering is designed to support small emerging biotech companies that are developing a drug in clinical trials. We understand that small companies face unique challenges in the drug development process, including limited resources and expertise, and we are committed to providing comprehensive and customized support to ensure successful outcomes. Our services include:


We are committed to providing the highest level of support to help small emerging biotech companies navigate the complex regulatory landscape and produce high-quality clinical trial materials that meet regulatory requirements and investor expectations. By partnering with us, small emerging biotech companies can have peace of mind knowing that their CMC-related activities are being managed with the highest level of regulatory compliance and technical expertise and that potential risks are identified and mitigated early in the drug development process.

We help you with

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. 


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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