Data-driven and reliable, our regulatory affairs team is equipped with years of experience in submitting important regulatory documents in clinical research. As an emerging leader in regulatory affairs, our goal is to provide global regulatory capabilities to support your product and clinical trial.
Helping You Meet Regulatory Obligations, Every Step Of The Way
Our data-driven methodology allows us to deliver an accurate, and customized approach. Our regulatory affairs team supports the development of all important regulatory dossiers, including all pertinent regulatory submissions. Alongside preparing regulatory documents in clinical research for submissions, we also stringently review each document, ensuring the maintenance of quality. Our regulatory affairs team works hard to ensure every aspect of your clinical trial from protocol changes to reporting of AE/SAE is properly documented as per the FDA, IRB, and GCP guidelines.
— Maximizing Your Product Value
Clinical Trial Submissions & Marketing Authorizations
Minerva Research Solutions is a trusted partner and an integral member of many of our client’s regulatory teams. We aim to streamline all of our clients’ regulatory compliance processes through regulatory advisory and tech-enabled solutions. Our regulatory affairs experts strategize the most effective route for your product including submission of regulatory documents in clinical research to competent authorities and ethics committees, to successful marketing applications. While at the same time providing the necessary guidance required to ensure continual regulatory compliance.
We’ve established robust processes that enable appropriate regulatory documentation authoring and submissions, affordably, with little to no room for error. Remaining current with the regulatory regulations as they evolve allows us to keep all stakeholders up to date and advise them accordingly on all matters of regulatory affairs, ultimately maximizing product value.
What We Do?
Preparation, Coordination, & Management of Complex Regulatory Documents in Clinical Research
At Minerva Research Solutions, our regulatory affairs team implements FDA and IRB regulatory requirements for your clinical trial and stringently follows them. We not only focus on increasing recruitment rates for your clinical trials, however, we also focus on developing documentation and expediting submissions that improve the chances of success for your products.
Preparation of Major Regulatory Dossiers
Complex National Submissions of Regulatory Documents in Clinical Research
Quality Control Review of Each Document
Regulatory documents are essential documents in clinical trials that permit evaluation of the conduct of a clinical trial and the quality of the data produced. Proper preparation of these essential regulatory documents assists sponsors, monitors, and the sites in successfully managing their clinical trials. These are usually the first documents that are audited by the sponsors and the regulatory bodies to ensure the validity of the trial conduct and the integrity of the data collected.
With our years of expertise in providing regulatory services for clinical trials, we offer insight into regulatory bodies, preparation of all major regulatory dossiers and documents, expedited submissions of regulatory documents in clinical research, document responses to regulatory bodies’ requests for information, and participate in, or facilitate meetings with regulatory bodies.
Our team works hard on preparing and organizing regulatory documents as per the study protocols. All documents are prepared in standardized formats as required by the regulatory bodies. Some of these documents include FDA-1572, Financial Disclosure Forms, Site Contact Forms, Recruitment Materials, Lab & Pharmacy Manuals, and Study Materials. These materials are diligently uploaded onto each study’s RealTime-CTMS and where needed, submitted to the IRB.