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We designate a primary consultant or team that can be altered to meet the project’s needs and deadlines. Our goal is to keep each engagement running smoothly and ensure our clients get optimal insights and outcomes.
With Enkrisi’s pool of multi-specialty professionals, your assigned individual/team can draw on the team’s knowledge and the extensive resources of the entire organization. We also make use of our Pharmavirtua augmented intelligence platform to provide answers to any one-off queries you may have.
In order to provide the highest quality of services for our global clients, many of our consultants and staff members possess experience in addressing international issues. However, when more specialized expertise is required, we engage our network of affiliates across the world to supply additional support.
Reach out to us by filling out a form on our website or calling us at 866-365-7474. After providing us with details about the services you need, we will assign a team leader to outline your project and create a comprehensive proposal to get started.
Yes, if an even higher level of global expertise or entry into a specific market is necessary, we can call upon our expansive international associates to offer additional help.
At Enkrisi, our rates are tailored to meet the quality and expertise your organization requires. Our prices align with industry standards, and we would happily provide more details. For further information, please visit our website or contact us at 866-365-7474 for additional details.
Our Operations and Supply chain experts are experienced in selecting the ideal CMO for any project, as well as negotiating contracts with CMOs and other vendors. Should your require assistance pertaining to CROs, we can call upon our associates for additional help.
Our team can help you manage the oversight of your CMO and ensure your best interests are being served. We have the experience, resources, and insight to properly manage all aspects of the relationship, with a focus on quality results.
Should your require assistance pertaining to CROs, we can call upon our associates for additional help. Our consultants are available to act as your representative in discussions with the CRO, clinical sites/investigators, guaranteeing that all generated data is of high quality and complies with regulatory objectives.
Please let us know if we can be of any assistance – we’re here to help!
Our standard rates reflect the superior quality and specialized expertise that your organization will benefit from. They are comparable to industry standards.
No, we are not a contract manufacturing organization (CMO) or a contract research organization (CRO), but we can assist you in identifying the most appropriate CMO for your product and organizational needs. Our expertise allows us to provide insight into which CMOs offer the best services for your specific requirements, helping you to make an informed decision and choose the perfect partner.
No, we are not a network of freelance consultants. We are a corporation made up of full-time employees, with the occasional long-term contract consultant, and augmented by Artificial Intelligence (AI) technology.
Yes. At Enkrisi, our consultants can provide gap analyses/due diligence to clarify the regulatory complaint pathway of a product’s development and assess potential strategy and/or development data. Additionally, our team has developed advanced Artificial Intelligence (AI) technology which can assist with this process.
Yes, our regulatory, technical, and medical writing consultants write (or review) sections of BLAs/NDAs. They are familiar with how FDA prefers data to be presented, as well as how best to summarize the data for each CTD section.
The cost depends on multiple factors. With Enkrisi’s Supply Chain Planning and Oversight Group, you can be sure to take the most appropriate and efficient route for producing the data necessary for FDA approval. Our team of experts can work with you and your CMO to ensure a well-designed and well-conducted process that minimizes financial and timeline risk. Let us handle it so you don’t have to!
Yes. With Enkrisi’s Regulatory Oversight Group, our consultants are highly experienced in interpreting and responding to FDA’s comments. We’ll provide the necessary data for FDA approval with minimal financial and timeline risk. Let us take the lead on this so you don’t have to worry about it!
Enkrisi is the trusted U.S. Agent, from pre-INDs to RAC submissions. Our Regulatory Project Managers (RPMs) serve as liaisons between Sponsors and FDA by attending type A, B or C meetings per year and taking minutes at no additional charge. To maintain accurate tracking of all submissions and FDA correspondence, we have our own comprehensive regulatory database. We invite you to contact us with further queries – we’ll be glad to provide you with any information required.
Yes. At Enkrisi, our consultants are proficient in preparation for Important meetings related to Investigational New Drug (IND) such as End-of-Phase 1, End-of-Phase 2, pre-BLA/NDA, Type A and Type C meetings. Our team works with clients to determine which questions need to be addressed at FDA meetings and helps design the relevant protocols with the help of technical experts focusing on a specific study area. Our technical and medical writing consultants have unmatched expertise in creating comprehensive briefing packages and preparing protocols, development reports, and regulatory submissions to the FDA.
Yes. At Enkrisi, our consultants are equipped to provide an in-depth review of all relevant data from our years of experience in the industry and from the perspective of an FDA reviewer. They can identify the “red flags” that need to be addressed while presenting the data to the FDA. Furthermore, our team has developed sophisticated Artificial Intelligence (AI) technology which allows us to quickly and accurately complete these tasks, leading to time and cost efficiencies for our clients.
At Enkrisi, we have significant experience in scheduling and preparing for pre-IND meetings and IND submissions. Our team of experts can guide you through the entire process so that your product or development program meets FDA requirements.
Our consultants are experienced in preparing for pre-IND meetings and End-of-Phase 1, End-of-Phase 2, pre-BLA/NDA, Type A and Type C meetings. With our expertise, you can ensure that all necessary documents and items are gathered for successful submission to the FDA.
At Enkrisi, we have experts with intensive knowledge of preparing INDs and briefing packages from the perspectives of CMC, nonclinical, and clinical studies. Our team is highly trained to ensure that all necessary documents and items are collected to meet FDA’s requirements.
At Enkrisi, our familiarity with FDA processes makes us the perfect contact person for submissions and meetings. We have considerable experience in meeting with FDA on behalf of our clients, as well as helping them to prepare for such meetings. Our knowledge of the FDA process can be invaluable when it comes to medical device development milestones.
Our Regulatory Technical and Medical Writing Group is experienced in drafting and submitting successful marketing applications for Europe and Canada. We have also written CTAs successfully approved in Europe. Let us help you navigate the regulations of these regions to ensure your submissions are successful!
Yes.
No, we are not a Regulatory Publisher. Please contact us, and we’d be happy to discuss our partners.
Yes.
Enkrisi has experience with:
Blood-Derived Products, Cell, Gene and Tissue Therapy, Drug-Device Combinations
Drug delivery devices (autoinjectors, catheters, implanted pumps), Orphan Drugs, Vaccines
Yes, our consultants can provide a review of data from the perspective of an FDA reviewer and identify the “red flags” that need to be addressed in presenting the data to FDA.
Yes. We can help with process development and validation on-site or remotely.
Yes. We can help with formulation development and validation on-site or remotely.
Yes. We can help with stability program management and design on-site or remotely.
Yes. We can help with Vendor and Contractor Identification and Management on-site or remotely.
Yes. We can help with Supply Chain Services on-site or remotely.
Yes.
Yes, our Regulatory Project Managers are highly experienced and specially trained, and we also take advantage of advanced project management tools.
Our project managers have a unique blend of technical and industry expertise, including drug substance and drug product manufacturing, regulatory affairs, supply chain and quality, as well as prior consulting knowledge. When you work with us, we’ll assign an experienced project manager to your project who matches the goals of the assignment with their specific skillset.
Our project teams are composed of subject matter experts (SMEs) that meet the exact needs of each project, whether it be the production of drug substances or drug products, quality assurance/control or regulatory submissions. Through the guidance of our experienced PMs, our teams can successfully traverse through all phases of development to reach market launch. As projects progress, our PMs adjust team composition appropriately to ensure that situational changes and new requirements are met.
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744 South Street
Philadelphia, PA 19147
Call or Text
+1-866-ENKRISI (+1-866-365-7474)