In the early phase, we can assist your regulatory affairs, clinical operations, and program management teams with clinical development plans, medical literature searches and reviews, regulatory gap analyses, and initial and annual updates of INDs/IMPDs. 

As development progresses, we can support your team in the preparation of protocols and amendments, IBs, CSRs (including legacy and backlog CSRs needed for compliance), and briefing books and regulatory response documents. 

When it's crunch time, we are all-in with you and your team and can help you with all of your NDA, aNDA, and BLA submission documents. We've done preclinical, CMC, clinical pharmacology, and efficacy and safety modules, including integrated efficacy and safety analyses, and specialty documents, such as the question-based clinical pharmacology review document.

We can help you  prepare small or large batches of patient and event-level narratives; aggregate safety reports (eg, DSURs, PADERs, PBRERs, and ASRs); risk mitigation strategies/plans (REMS, RMP); and systematic and narrative literature reviews.

It is critical to require QC document reviews prior to management review, finalization, and submission. Let us help you catch errors and inconsistencies in your regulatory, medical/ scientific affairs, and drug safety/PV documents. 

We check data against sources, but we are also experts at ensuring internal and between-document consistency in terms of content, style, and format. We can use your company's document-specific QC checklists and verification forms, or we can use and/or customize our checklists. Need online or in-person training? We can help with that too!

From strategic asset reviews to building core slide libraries, print and online training modules, objection handling materials, and annotated journal articles or package inserts, we can work collaboratively with your team to create all types of medical/scientific sales and MSL training materials.

Meet your company's reporting and transparency commitments with clinicaltrials.gov and other clinical trial registries. 

Communicate your studies and their results using plain-language summaries and graphical abstracts.