ACADEMIA INDUSTRY

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:

GMP Compliance:

We will identify and assess CMC-related risks and develop strategies to mitigate them throughout the drug development process.

Quality System Implementation:

We will help you implement a robust quality system to ensure that the drug product is manufactured in compliance with current regulatory standards.

CMC Risk Management:

We can also provide regulatory support to the drug sponsor, such as reviewing and advising on CMC-related documents, to ensure that the clinical trial materials are manufactured in compliance with regulatory requirements.

CMC Project Management:

We will serve as an extension of your team to provide CMC project management and ensure that timelines and milestones are met.

Technical Writing:

Our team of experienced technical writers will provide support for authoring and reviewing CMC-related documents, including INDs, BLAs, and CTAs.

Regulatory Submissions:

We will prepare and submit all necessary regulatory documentation to ensure that your drug development program stays on track.

CMC Strategy Development:

We will work with you to develop a comprehensive CMC strategy that meets regulatory requirements and aligns with your drug development goals.

OUR COMMITMENT

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

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.

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.

TRUSTED BY

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

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