Our Dossier Preparation and Submission Support Services are designed to simplify regulatory approval processes for the life sciences and pharmaceutical industries. We assist organizations in preparing and submitting high-quality, compliant dossiers tailored to specific country requirements, ensuring seamless product registrations and minimizing approval timelines.
We specialize in the collection, assessment, and processing of Individual Case Safety Reports (ICSRs), managing Adverse Drug Reactions (ADRs) and Adverse Events (AEs) throughout the entire product lifecycle. Our services include precise data entry, coding using MedDRA, and expert narrative writing to ensure accurate and compliant safety reporting.
We ensure compliance with GDPR, HIPAA, and other regional data privacy laws, offering secure transfer and storage of sensitive regulatory data to protect confidentiality and integrity.