We make work!

Streamlining the trial master file and regulatory submissions management process to expedite drug approval.

Where reliability and expertise converge…

…you garner the benefits of the Corementum experience. With over 40 years of combined experience working with biotechnology and pharmaceutical companies, we offer what very few can…excellence!

Learn more about Corementum’s Clinical and Regulatory solutions.


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eTMF and Regulatory Submissions Management Options

Regulatory Submissions Management

We assist our clients in managing all regulatory submissions documentation to be submitted to the agencies to ensure processing and timely approval. Our expert team will ensure that all of your documents are in compliance with the most current agency eCTD specifications so as to eliminate the chance of refusal to file (RTF).

Information Management

Corementum ensures that all of your trial data is properly classified, complete and meets agency standards and guidelines. There’s no need to research guidances and regulations, we do the work so you don’t have to.

eCTD Process Planning & Implementation

We assist clients in eCTD conversion, reports/submissions publishing, submissions planning, vendor and system selection/implementation

eTMF Process Planning & Implementation

Per agency requirements, we help clients transition from a paper-based documentation system to an industry accepted eTMF system. This helps our clients stay abreast of the latest in document management technology so they are prepared for future inspections.

Compliance Oversight

Our team specializes in agency regulations. We ensure that your documents meet these standards prior to partner or agency inspections, and submission. Our clients rely on our years of experience and expertise when it comes to agency regulations, saving them the time and headache of having to take care of it themselves.

Trial Master File Management, Document Preparation and Regulatory Submissions' Planning for Agency Approval

We help our clients properly prepare all of their trial master file documents to meet or exceed the standards set for partner and agency’s inspections. This includes helping them transfer over from paper-based to eTMF documentation as well as assuring proper indexing and inclusion of all necessary documentation required to support the safety and efficacy of the drug.

Create Your Corementum Experience

At Corementum, we have identified a need for improvement in the Clinical Operations and Regulatory Operations processes for our clients in order to help them achieve quick and proper agency approval for their applications. Our first-hand experience has allowed us to deliver hands-on regulated content management assessment, guidance, and instruction for every major part of a life sciences company, from R&D document development, to Trial Master File (TMF) management and implementation, to Regulatory submissions. Our team of experts addresses your specific concerns and creates a strategy that helps you maximize your current and future investments in systems, processes, and resources. We take the worry out of compliance regulations with our unique programs using the most up-to-date agency recommendations. Corementum cuts through the red tape and expedites the process for agency approval for your regulatory applications.

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