The experienced Aptiv Solutions medical-writing team is fully integrated with our clinical operations, ensuring that your key messages are medically and scientifically sound and acceptable to clinical, regulatory and reimbursement audiences.
Our writers skillfully handle writing projects related to drugs, biologics, and medical devices, and have experience with complex medical research topics such as proteomics, epidemiology, and pharmacogenomics. We have established procedures for document management and a broad collective experience in current electronic submission formats and standards. Just as important, all documents undergo rigorous quality assurance review before delivery.
- Team includes veteran clinicians, statisticians & scientists
- Dedicated Medical Writers with experience across multiple therapeutic specialties
- Study-related material (IB, protocols, CSRs)
- Regulatory-associated material (ISS, ISE, IND, IDE, NDA, BLA, PMA components)
- Manuscript preparation
- Technology platform with audit-ready version control & tracking