Our Expertise, Your Advantage
Medical, Scientific & Technical Writing
Bridging Knowledge & Clarity
MDL Therapeutic Research delivers integrated Medical Writing Solutions with a focus on various therapeutic domains, including vaccines and medical devices. Our skilled team collaborates effectively with biostatistical, pharmacovigilance, project management, and clinical data management experts to ensure the creation of accurate, timely, and compliant documentation.
Medical & Scientific Writing Support for Diverse Document Types:
- PIP part F and part A
- PIP Key Elements Form
- Nonclinical/CMC documents
- Orphan Drug Annual Report
- Actual Orphan Drug Application
- Original Pediatric Written Request (FDA)
- PIP Scientific Document (parts B-E, includes waiver)
- Orphan Drug supporting Briefing Books (BB) and updates
- Module 2.4, 2.5, 2.6 & 2.7 (Clinical & Non-clinical summaries)
- Proposed Pediatric Study Request/Pediatric Study Plan (PPSR/PSP) + modifications
- Correspondence with Health Authorities and Cover Letters including Meeting requests.
- Scientific Advice Document/Documents for EU Scientific Meetings and other ROW HA meetings
- Clinical Overview (CO) to support global submissions, (c)MAA, (s)BLA/(s)NDA, Type II variations, etc.
- PIP Update (request for PIP modification), including final consolidation of comments after HA approval
- DSMB charter
- Statistical Analysis Plan
- Protocol Registration Forms
- Protocols for epidemiology studies
- Protocol Clarification Communication
- List of anticipated events in protocols
- Informed Consent Form (including Master ICF)
- Clinical Study Protocols for Phase 0, I to IV studies
- Amendments/Revisions for Clinical Study Protocols
- Protocol Synopsis / Protocol design / Protocol Outline
- Responses to Ethics Committees and Regulatory Agencies
- PK Reports
- Modeling Reports
- CSR Appendices
- Clinical Subject Narratives
- DMC/DSMB Report Package
- CSRs for Epidemiology studies
- CSR Addendum/Erratum/Synopsis
- PRCI (Public Release of Clinical Information) Health Canada
- CSR body (full, abbreviated, synoptic) for Phase 0, I-IV studies
Regulatory Medical Writing
1
Start-up Phase
- Investigators Brochure
- Protocols and ICDs
2
Conduct Phase
- Pre Database Lock Narratives
- Shell Clinical Study Report (CSR) with mock tables
3
Closure
- Post Database Lock Narratives
- CSR with appendices
4
Post Study Phase
- eCTD Modules
- Summary/Health Authority Documents
Our process in four easy steps
1
Aggregate Reports
- DSUR/PBRER/PSUR/PADER/SUSAR LL
- Protocols and ICDs
2
Risk Management Plan
- EU/ Core