Poorly written documents can be frustrating to read, and any message can all too easily be lost. At worst, this can result in additional questions from Regulators and possible delays to your procedure.
To address this problem, VCLS has built up a network of highly experienced medical writers with proven track records, and with the skill and experience to draft a wide variety of pre- and post-authorisation documents. This network is supplemented by in-house experts, many of them ex-Assessors, who bring with them their own specific insights into the expectations of Regulators.
Whether as a stand-alone service, or in combination with other services, VCLS is able to craft your documents so that they are delivered to the required audience in the most appropriate language, and in the most effective way.
VCLS has extensive experience of creating a wide variety of pre- and post-authorisation documents, including:
- Investigator Brochures (IBs) and annual updates
- Investigational New Drugs (INDs)
- Clinical Study Reports (CSRs)
- Clinical Evaluation Reports (CERs)
- Policy 70 support, advice, authoring and the redaction of applicable clinical documents (eg CSRs, Summaries and Overviews)
- All Modules for the Common Technical Documents (CTDs), including Summaries and Overviews
- Regulatory Authority meeting briefing packages (e.g. National Scientific Advice, Oral Hearings, Discussion Meetings etc.)
- Responses to regulatory authority questions
- Orphan Drug Designation (ODD) requests
- Paediatric Investigation Plan (PIP)
- Investigational Medicinal Product Dossiers (IMPDs)
- Periodic Safety Update Reports (PSURs) / Development Safety Update Reports (DSURs)
- Environmental Risk Assessments
- Medical Device dossiers
- Value proposition
- Core value dossier
- HTA & Reimbursement dossier
- AMCP dossier
- Manuscripts, journal articles, and white papers
80+ CTA/IND submissions 10+ MAA/BLA