Regulatory Affairs


Navigating Regulatory CMC Success: Expert Services for Drug Development and Commercialization

The company provides regulatory CMC strategy and due diligence services for clients developing small molecules, biologics, devices, biosimilars, and combination products. They offer guidance on Orphan Drugs Designation, Fast Track, Break-through Therapy, Accelerated Approval, ANDA, and 505(b)(2) submissions.

Enkrisi specializes in FDA submission services, including technical and medical writing, authoring and reviewing submissions and assisting with refining regulatory strategy.

Additionally, the company provides FDA meeting preparation and engagement consulting services, including representing clients in interactions with the FDA, assisting with preparations for FDA interactions, and providing an ‘FDA-style’ review of submissions.

How we can help

For many biotechnology companies, maintaining a full complement of product development experts, from drug development technical experts to submission authors and regulatory professionals is impossible. However, lacking access to these experts hinders the progress of product development.

How we can help

For many biotechnology companies, maintaining a full complement of product development experts, from drug development technical experts to submission authors and regulatory professionals is impossible. However, lacking access to these experts hinders the progress of product development.

What makes Enkrisi your ideal choice?

Our regulatory support, quality assurance, and compliance services cover all aspects of product development and manufacturing, including the assessment and evaluation of stability data and requirements, preparation and review of gap assessments and regulatory submissions, and risk-based strategies for product development and post-licensing approval. We also offer oversight of contract services, including CMOs, to ensure that manufacturing processes comply with regulatory requirements and meet high-quality standards.

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,


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.

Lets discuss your product