Medical Writing and Quality Control
We know that quality is the most important factor in producing any document. At IMPACT, our medical writing services will provide you with the highest quality documents by utilizing a team of PhD-level Clinical Research Scientists who are not only medical writers but have years of proven experience in clinical drug development and regulatory affairs. Our highly experienced team is committed to quality and will provide you with a clear, concise, and scientifically/medically accurate document.
Our commitment to quality includes:
- Authoring documents that are in compliance with ICH and regulatory requirements.
- Delivering documents following the highest level of internal review and independent quality control.
- Working according to Standard Operating Procedures, whether it be a client’s SOPs and templates or providing our own standardized ICH-compliant templates.
- Providing ‘publish-ready’ documents.
- Delivering on time.
Medical Writing Services
Our team of professionals has broad experience in regulatory and non-regulatory medical writing, including:
- Protocols
- Clinical Study Reports (CSR)-full, abbreviated and synoptic (all phases)
- Investigator’s Brochures (IB)
- Subject information sheets (Informed Consent Forms)
- Patient narratives
- Manuscripts, abstracts, posters
- Investigational New Drug (IND) Applications
- IND/NDA annual reports
- FDA Meeting Information Packages
- New Drug Applications (NDA)
- Supplemental NDAs (sNDA)
- Abbreviated NDAs (ANDA)/505(j)
- 505(b)(2) applications
- NDA components: Clinical Overview (2.5), Summary of Clinical Efficacy (CSE, 2.7.3), Summary of Clinical Safety (CSS, 2.7.4), Integrated Summary of Effectiveness (ISE), Integrated Summary of Safety (ISS), Nonclinical Summary (2.6), Nonclinical Overview (2.4)
- Biologic License Applications (BLA)
- Orphan Drug Applications