Services

If You’re Looking For Smooth and Seamless Agency Submissions For Your Regulatory Applications Look No Further

Corementum’s goal is to help clients not only manage their documentation and submission of clinical trial data for agency approval, but to understand the process of doing so. We educate our clients every step of the way so they better understand the agency regulations and expectations. This helps us help our clients complete their submissions properly the first time, reducing rejection and the need for numerous resubmissions and saving precious time.

We assist our clients in managing all regulatory submission 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).

Regulatory Submissions 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.

Information Management

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.

eTMF Process Planning & Implementation

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.

Compliance Oversight

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.

Trial Master File Management for Agency Approval

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

eCTD Process Planning & Implementation

Corementum Has The Services You Need With The Knowledge And Expertise You Can Trust

Our clients’ success equals our success. When we assist our clients in achieving their business goals, we know it’s been a great day at the office. Our Corementum team members are passionate about what they do and look forward to working with you on your next project.

Interested in learning more about what Corementum can do for you? Contact us by filling out the form below. We’d love to hear from you!

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