Regulatory Services

Reinventing Site Regulatory & Study Compliance

Minerva Research Solutions provides sponsors, CROs, and research sites with customized and innovative regulatory services and solutions that ensure site compliance, monitor-readiness, and effective management of their clinical research study information. We offer extensive industry experience through all phases of the drug-development process to meet diverse regulatory requirements.

From study startup to study conduct, we aim to provide quality and efficient regulatory support services that enable the success of those study trials and the prompt granting of marketing authorizations. Through our proactive approach and careful counseling on regulatory requirements, we aim to provide continual regulatory compliance.

— What We Offer

Amplifying Compliance through our Regulatory Services

Minerva Research Solutions is a leading full-service clinical trial operations and regulatory support services provider. We provide insight into regulatory processes, expedite IRB and other regulatory bodies’ submissions, respond to regulatory bodies’ requests for information, prepare, coordinate and manage complex regulatory meetings and submissions.

We remain up-to-date with the latest regulatory requirements as they evolve. Through our streamlined communications, we aim to keep all stakeholders informed and engaged with every detail of the clinical trial. As a crucial part of our regulatory support services, we have extensive experience in comprehensive monitoring and documenting your clinical trial.

Insights into our Comprehensive Regulatory Support Services

Our regulatory affairs team ensures accurate completion of regulatory requirements while enabling rapid execution of our regulatory expertise.

Regulatory Services

Documentation

Enabling rapid & accurate collection preparation of all site documents.

Accelerating

Study Startup & Activation

Reducing clinical trial lifecycle & maximizing enrollment period.

Stringent Processes

Ethics Committee & Review Board Submissions

Accurate & stringent submissions timelines, reducing study lifecycle.

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Have questions?

What regulatory support services does Minerva Research Solutions offer?

At Minerva Research Solutions, our qualified regulatory affairs team provides regulatory consulting and complete study management from early clinical development to clinical trial submissions and marketing authorizations.

What is your regulatory approval process?

With our extensive industry experience, our regulatory team aims to meet diverse regulatory requirements. We receive all of our approvals from the FDA and the IRB. We prepare and submit all major regulatory dossiers as per the requirements of the FDA and IRB.

Which regulatory authorities are responsible for approving clinical trials?

Regulatory authorities are those bodies that are responsible for reviewing submitted clinical data and those that conduct inspections. To conduct clinical trials, sponsors or CROs require approvals from all government or health authorities including U.S. Food Drug and Administration (FDA) and Institutional Review Boards (IRB). The majority of the clinical trials are subject to Food and Drug Administration (FDA) regulations and human subject protection laws.

Why partner with Minerva Research Solutions?

Minerva Research Solutions has an experienced regulatory team and qualified research staff. We ensure full-range services for your phase I-IV clinical trials including regulatory approvals and post-marketing services. Our team ensures continuous regulatory compliance, risk reduction in study startup, monitoring, audit, inspections, and successful closeouts.