At Ficus Realtime, we provide comprehensive Regulatory Support Services to help life sciences and chemical companies comply with national and international regulations. From compiling technical documentation to managing regulatory submissions, our team ensures your products reach global markets faster and fully compliant.
At Ficus Realtime, we provide specialized regulatory support services to help pharmaceutical, biotech, and chemical organizations navigate complex regulatory pathways with confidence. From dossier compilation to product registration, we ensure your documentation meets the highest international standards—accelerating approvals and minimizing compliance risks.
Dossier Preparation
We create high-quality, well-structured dossiers in accordance with global regulatory formats such as:
*CTD / eCTD (Common Technical Document / electronic CTD)
*ACTD (ASEAN CTD)
*DMF / ASMF (Drug Master File / Active Substance Master File)
*CEP submissions (Certificate of Suitability to the monographs of the European Pharmacopoeia)
Our dossiers cover:
Administrative and product information
Quality (CMC) documentation
Non-clinical and clinical data (where applicable)
Risk assessments and justifications
Stability, validation, and testing summaries
Testimonials
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
ISO INFORMATION SECURITY MANAGEMENT SYSTEM
NSJ PRAYOG LIFE SCIENCES PVT.LTD
CERTIFICATE OF EXCELLENCE - KeacGMP & CSV
