FicusRealtime offers specialized support in the development, qualification, and regulatory compliance of biological products—including vaccines, monoclonal antibodies, biosimilars, recombinant proteins, blood products, and cell & gene therapies
Biologicals are highly complex and sensitive, requiring precise handling, validated manufacturing processes, and strict regulatory oversight. We work closely with your team to ensure quality, safety, and compliance from R&D to commercial launch.
Our Services Include:
Biologics Regulatory Strategy:
Regulatory pathway selection: IND, BLA, biosimilars
Dossier preparation in CTD/eCTD format
Global compliance: FDA (CBER), EMA, CDSCO, WHO, ICH
Quality Systems & GMP Compliance:
Design and implementation of biologics-specific QMS
Process validation: upstream (cell culture), downstream (purification)
Cleaning validation, aseptic process validation
Facility qualification (HVAC, cold storage, biosafety levels)
Analytical & Stability Support:
Analytical method development and validation (ELISA, bioassays, etc.)
ICH-compliant stability testing for biologics
Cold chain validation and packaging qualification
Documentation & Audit Readiness:
Batch manufacturing records and quality documentation
Risk assessments, deviation investigations, and CAPA support
Pre-approval inspection (PAI) and regulatory audit preparedness
Industry-Specific Software for Enhanced Quality and Compliance
Testimonials
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
NSJ PRAYOG LIFE SCIENCES PVT.LTD
