Staff Augmentation & Training
Navigating Regulatory CMC Success: Expert Services for Drug Development and Commercialization
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.
Learn more about Staff Augmentation
How we can help
How we can help
Staff Augmentation & Training
What makes Enkrisi your ideal choice?
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. Our team of experts can provide the necessary knowledge, expertise, and support to help companies achieve their goals while ensuring compliance with regulatory requirements.
Your success,
stories
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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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.
