BIOTECH INDUSTRY

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

Streamlining drug development with CMO expertise.

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 services from development and formulation to clinical trial and commercial production. Enkrisi can help its clients by providing cost-effective and efficient manufacturing solutions, allowing them to focus on other aspects of drug development, such as research and marketing. CMOs must comply with the same regulatory requirements as their clients and ensure that their manufacturing processes meet the necessary quality standards. Our team of industry experts can help both emerging biotechs and established CMOs understand and stay 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, our team is here to assist you in developing an overall strategy that accounts for all potential risks while still meeting your objectives. Let us help make the complex world of compliance more manageable than ever!

We help CMO/CROs tackle these challenges.

In addition to our comprehensive CMC regulatory services, we understand that CMOs must balance the demands of their clients with the regulatory requirements of drug development. To help CMOs manage drug sponsors and ensure that they can concentrate on their primary job of manufacturing clinical trial materials, we offer the following additional services:

Sponsor Communication:

We can serve as a liaison between the CMO and the drug sponsor to ensure clear and timely communication.

Project Management:

Our team can provide project management support to help the CMO manage timelines and deliverables, freeing up their resources to focus on manufacturing activities.

Technical Support:

Our technical experts can provide guidance to the CMO on manufacturing issues, such as process development, scale-up, and validation, so that they can ensure the quality of the clinical trial materials.

Regulatory Support for Sponsors:

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.

OUR COMMITMENT

Our goal is to provide comprehensive support to CMOs so that they can concentrate on their primary job of manufacturing clinical trial materials while we take care of the regulatory and project management aspects of drug development. By partnering with us, CMOs can streamline their operations, minimize risk, and ensure successful outcomes for their clients.

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

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.

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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.