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.
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20K+ Satisfied Clients World Wide
Deployed a Professional team and Accomplished The Successfull completion of the CSV Project with in our Organization.They Delivered a High Quality out for Chromotography and purified Water System Integrated with PLC-HMI Systems All while ensuring strict adherence to Regulatory standards.
Mangalam Organics Limited
VINS BIOPRODUCTS LIMITED
ORCH Laboratories India Pvt.Ltd
Extrovis Private Limited
ISO Quality Management System