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


Challenges in bringing academic discoveries to market

Products developed out of academia refer to innovative products from research conducted in academic institutions such as universities or research institutes. These products may include drugs or other types of technology that have the potential to address unmet medical needs and improve patient outcomes. Bringing academic discoveries to market involves collaboration with industry partners, navigating regulatory requirements, and securing funding and intellectual property rights.

These emerging companies often lack familiarity or experience with regulatory requirements, which can lead to failure to achieve market approval. Management in these companies focuses on clinical development strategies, often neglecting the development of a viable and practical chemistry, manufacturing, and controls (CMC) regulatory compliance strategy. Effective CMC regulatory compliance is critical in introducing an investigational new drug (IND) into humans during Phase 1 clinical studies to ensure human safety. Key messages for sponsor companies regarding CMC regulatory compliance include taking responsibility, assessing risks for complex processes and products, and focusing on risk control rather than just regulatory compliance.

Producing investigational medicinal products in Phase 1 clinical trials is complex and challenging, requiring competent CMC staff and consultants to guide management in the appropriate application of risk controls.

We assist academia in overcoming these obstacles.

Our CMC regulatory service offering is tailored to support academia in developing a drug through clinical trials. We understand the unique challenges and regulatory requirements faced by academic institutions in drug development, and we are committed to providing comprehensive and customized support to ensure successful outcomes.Our services include:


Our team consists of regulatory experts with extensive experience in drug development and CMC, including former FDA reviewers. We are committed to providing the highest level of support to help academic institutions navigate the complex regulatory landscape and bring their drugs to market.

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.