Production, Generation & Submission of Aggregate Reports (PBRERs, PADERs, ASRs & DSURs)
- Production of Product Specific Line Listings.
- Complete authoring and production of PEBRERs/PSURs, PADERs, DSURs, Addendum to Clinical Overview (ACO).
- Compliant Formats: ICH E2C, GVP Modules; US FDA CFR Part 314.80.
Risk Management Plans / REMS
- Authoring and preparation of EU RMPs and REMS.
- Help & Support with preparation of Medication Guides, Educational Materials and other Risk Minimisation Plans.
- Help & Support with Survey and testing as a measure of effectiveness of RMP/REMS with patients and prescribers.
Labelling: IB; SmPC, PIL, CCDS & USPI
- Preparation and authoring of labelling documents and Reference Safety Information for products (CCDS, SmPCs, IBs, PILs)
Other Medical Writing Services
- ICSR Narratives—Company Assessment & Comments
- Causality Assessments
- Risk Benefit Assessments
- Analysis of Similar Events
- Integrated Safety Summary (ISS)
- NDA Clinical Report Safety Sections
- Patient Profiles for Different Phases
- Preparation of Clinical Overview & Clinical Summary
- Preparation , authoring & maintenance of PSMF
- Phamacovigilance Plans
- Dear Doctor & HCP Letters