Services

At Medical Writing Solutions, we specialize in generating nonclinical regulatory documents with meticulous attention to detail to support your submission and ensure regulatory compliance. We adhere to Common Technical Document (CTD) specifications for dossier management and are adept at following Sponsor-specific templates and style guides. Additionally, we are proficient in a suite of software programs, including but not limited to Veeva Vault RIM, EndNote, and GraphPad Prism.
 

Our Expertise Includes:

• Briefing Documents: Comprehensive documents to facilitate clear communication with global health authorities.

• Response Documents: Detailed responses to health authority queries and requests for additional information during the regulatory review process.

• Investigator's Brochure (IB): Detailed information for clinical investigators on the drug product.

• Development Safety Update Report (DSUR): Regular updates on the safety profile of the drug product.

• Investigational New Drug (IND) Applications: Complete submissions to initiate clinical trials for new drugs.

• Clinical Trial Applications (CTA): Applications required to obtain authorization to start clinical trials.

• New Drug Applications (NDA): Comprehensive submissions for seeking approval to market a new drug.

• Biologics License Applications (BLA): Detailed submissions for approval to market a biologic product.

• Marketing Authorization Application (MAA): Submissions to seek approval for marketing a new drug.

• Nonclinical Study Protocols and Reports: Developing and reviewing both study protocols and reports, with specific attention to Good Laboratory Practice (GLP) and non-GLP study requirements.