EXPLORE OUR SERVICES
Regulatory Affairs
Chemistry Manufacturing
& Controls
Quality Assurance
Program Management
Staff Augmentation & Training
Regulatory Affairs
- Support clients developing small molecules, biologics and combination products
- Evaluation and guidance on all aspects of regulatory strategy for product development
- Orphan Drugs Designation, Fast Track, Break-through Therapy, Accelerated Approval, NDA, BLA and 505(b)(2) submissions
- Conduct due diligence
- Represent clients in interactions with FDA and EMA
- Assist with preparations for FDA interactions
- Advise on regulatory options and potential pathways
- Technical and Medical Writing
- Author and/or review IND, IMPD, NDA, BLA, DMF, and CTA applications, amendments and supplements
- Design or assist with the design of regulatory strategy
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Chemistry Manufacturing & Controls
- Formulation, process, and analytical method development
- Validation
- Regulatory, Quality Assurance & Compliance services for drugs and biologics
- Assessment and evaluation of stability data and requirements
- Preparation and review of gap assessments and regulatory submissions
- Risk-based strategies for product development
- Supervision and operation support of contract services, including CMOs
Our CMC development consulting services offer comprehensive support for clients developing pharmaceutical drugs and biologics, including formulation development, process, and analytical development, validation, and quality-based manufacturing and analytical method development.
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.
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Quality Assurance
- Gap assessments, PAI readiness, Audits
- Design, Implementation and Remediation of Quality Systems
- Vendor Qualification, Inspections and Mock Pre-approval Audits
- Management of GMP/Compliance Situations
Our audit services cover a range of areas related to regulatory compliance, including GMP and facility audits, CMO audits, and Quality System audits to ensure that clients meet regulatory requirements. Our expertise in conducting these audits includes identifying areas of non-compliance, providing recommendations for improvement, and ensuring that clients have the necessary documentation to demonstrate compliance.
In addition to these audits, we also offer gap assessments and PAI readiness assessments to help clients identify areas where they may be falling short of regulatory requirements and ensure they are prepared for any regulatory inspections. We also provide guidance and support for clients seeking commercial readiness for their products.
Our data audit services cover data integrity and validation to ensure that clients’ data is accurate, complete, and reliable. We help clients assess the integrity of their data, identify potential areas of concern, and develop strategies to address any issues.
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Program Management
- Employ a full roster of consultants in every area of pharmaceutical, development,
- Offer the opportunity to make our team yours, on-demand,
- Provide a team able to step in to expand your current team,
- Work with firms of all sizes on projects of all magnitudes,
- Bring unique industry insider perspective to each engagement
Enkrisi has designed a unique solution to address this issue with our Staff Augmentation offerings.
The staff augmentation and training services provided by Enkrisi are practical solutions to address the issue of limited access to product development experts. Our team of former industry scientists and FDA reviewers, who adhere to high professional standards, can provide clients with access to a full roster of consultants in every area of pharmaceutical, biologic/biosimilar, and therapeutic product development. This means that clients can leverage their expertise and experience to fill gaps in their current team while benefiting from a world-class staff at a fraction of the cost.
By offering their team on-demand, Enkrisi can work with firms of all sizes on projects of all magnitudes, providing the necessary resources to help accelerate development timelines. Our unique insider perspective allows us to maximize the value of every dollar spent, which can be especially valuable for companies with limited budgets. Additionally, our regulatory training services can help ensure that a client’s team and the entire company are knowledgeable, informed, and prepared to navigate the complex regulatory landscape.
Overall, the staff augmentation and training services provided by Enkrisi can help companies overcome resource limitations and accelerate the development of their products. Ourteam of experts can provide the necessary knowledge, expertise, and support to help companies achieve their goals while ensuring compliance with regulatory requirements.
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Staff Augmentation & Training
- Strong knowledge of FDA regulations, guidance and expectations based on direct experience,
- Interact with FDA project managers and reviewers on a daily basis as the primary point of contact
- Provide regulatory and product development guidance,
- Serve as a primary point of contact for project coordination,
- Accompany Sponsors to FDA meetings and participate in teleconferences.
Project management services provided by Enkrisi Project Managers are comprehensive and practical for the successful execution of projects. Their robust knowledge of FDA regulations and guidance, as well as their experience interacting with FDA project managers and reviewers, make them valuable resources for US Agent clients who seek to navigate the regulatory landscape. Additionally, their ability to follow trends and provide regulatory and product development guidance can help clients stay up-to-date and compliant with evolving industry practices.
As primary points of contact for project coordination, Enkrisi Project Managers can help streamline the writing, review, strategy discussions, publishing, and application life cycle maintenance activities critical to achieving project success. They can also advise on optimal practices for creating efficient and reviewer-friendly applications, which can improve the likelihood of a successful review outcome.
Finally, Enkrisi Regulatory Project Managers can provide regulatory and submission guidelines to clients and accompany sponsors to FDA meetings, which can be instrumental in obtaining regulatory approval. By participating in teleconferences, they can provide valuable insights and expertise to support clients throughout the project lifecycle. Overall, our project management services are a valuable asset to any organization seeking to bring a product to market while complying with regulatory requirements.
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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.
