Reimagine Your Regulatory CMC Program with Expertise and AI Excellence

Our company offers a comprehensive service to emerging biotech companies to help them navigate the complex world of product development, including establishing a concise CMC development and regulatory strategy and plan. We understand the challenges of developing a product and taking over contractors while trying to keep spending to a minimum until certain clinical milestones are met. We can help you make informed decisions, identify associated risks, and develop a plan to mitigate those risks. Our team of experts can help you with everything from clinical trial management to approaching regulatory agencies, ensuring you have the best package possible to achieve success.

Enkrisi offers a service for established pharma companies developing a mature clinical target or considering in-licensing a product with phase 2 or 3 clinical data but lacking CMC development data. Our team addresses these issues promptly and evaluates what needs to be done to fill the gaps while considering all costs and risks. We help clients determine whether the project is worth pursuing, which regulatory discussions will be necessary, and build the Quality Modules of the marketing application. Leveraging data, apps, and platforms with Augmented Intelligence (AI), we provide expert guidance and ensure your drugs are optimized for success in the life sciences industry.

We offer regulatory consulting services to help emerging companies that have developed products out of academia navigate the complex world of regulatory requirements. Our team of experts can help these companies develop a viable and effective chemistry, manufacturing, and controls (CMC) regulatory compliance strategy that meets regulatory standards, reduces risks, and improves patient safety. We can also guide you on securing funding and intellectual property rights, collaborating with industry partners, and navigating the regulatory landscape to bring academic discoveries to market. With our services, emerging companies can focus on clinical development strategies while we handle the regulatory compliance aspect of their product development.

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 a range of services from development and formulation to clinical trial and commercial production. Enkrisi offers support by providing cost-effective and efficient manufacturing oversight, offering services from development and formulation support. Our team of industry experts can assist established CMOs, and their emerging biotech customers in understanding and staying 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. We can assist you in developing an overall strategy that accounts for all potential risks while still meeting your objectives, making the complex world of compliance more manageable than ever.

Enkrisi is a service that provides comprehensive due diligence activities to assist in the in/out licensing of pharmaceuticals for commercialization. This involves a detailed investigation of the CMC information to ensure the technical and quality elements are met for successful drug product commercialization. Enkrisi also advises organizations on CMC aspects of regulatory submissions, development and implementation of CMC regulatory strategy, and identifying and assessing regulatory risks, based on strategic CMC regulatory expectations and government agencies’ regulations on medicines. This service particularly benefits VCs in younger established Pharma and smaller emerging Biotech companies involved in reviewing development data expectations.