REGULATORY WRITING. Current services include writing and editing of regulatory documents for clinical research and FDA submissions for drugs, biologics, and devices. We have direct experience with FDA-CDER, CBER, and CDRH submissions, meetings, and engagement. We are also IRB members and reviewers for studies involving drugs, biologics, and devices. As such, we can provide regulatory feedback on clinical protocols and informed consent documents for likely regulatory and operational challenges.
REGULATORY PUBLISHING. The looming eCTD mandate from FDA represents additional costs and learning curves for small to mid-size companies. SciMedLit understands the challenges of the paper-to-electronic conversion, and has several nimble strategies to assist you - including outsourcing services. For device companies, SciMedLit can assist in creating CDRH eCopy-compliant submissions.
MEDICAL WRITING. Other services include grant proposals, manuscripts, posters, and slide decks.
EDITING. There are two levels of editing service - copyediting and substantive editing. At minimum, services include corrections and/or improvements to spelling, grammar, style, usage, and syntax.
PRE-PEER REVIEW. For editing projects, this optional add-on service provides a summary of perceived document strengths and weaknesses that may affect the outcome of peer review by regulatory, funding, or publishing bodies. This asset is possible through our scientific and regulatory expertise, and "anticipating rebuttal" can considerably improve your chance of success.