We understand the importance of a clinical trial that is written in a clear and precise manner which is easily understood by IRB, FDA, and any other reviewers. It is risky to submit a poorly written protocol which leads to a huge loss in time and money. Further, delays and additional revisions can have significant cost implications. However, our qualified regulatory medical writing services helps you in composing a well-written clinical trial and ensures that your clinical trial protocol is reviewed, edited and proofread properly that helps you save time and money and importantly the reputation of you/your organization.
Our team has the capabilities and skills to prepare regulatory submission documents required to seek US Food and Drug Administration (FDA) approval for drugs and devices. The Medical Writing Solutions we offer include regulatory compliance solutions in preparing essential documents for clinical trial submissions such as investigator brochures (IBs), protocols, common technical documents (CTDs), eCTD modules, periodic safety update reports (PSURs), development safety update reports (DSURs), annual safety reports (ASRs), clinical study reports (CSRs), documents related to pharmacovigilance like risk management plans (RMPs), periodic safety update reports (PSURs) and other associated documents. Our experts hold vast experience in handling several therapeutic areas including immunology and vaccines.