Ficus Realtime

Biotechnological Industries

At Ficus Realtime, we specialize in supporting the biotechnological industry with end-to-end services in regulatory compliance, quality management, validation, and documentation. As biotech companies develop complex products like vaccines, biosimilars, therapeutic proteins, enzymes, and cell & gene therapies, we ensure that each step meets global regulatory expectations. We help biotech organizations streamline development, optimize manufacturing processes, and navigate regulatory submissions across international markets.

As biotech companies develop complex products like vaccines, biosimilars, therapeutic proteins, enzymes, and cell & gene therapies, we ensure that each step meets global regulatory expectations.

Our Core Offerings for Biotech Companies:
Regulatory Guidance & Submission Support:
IND/BLA/ANDA/MAA dossier preparation (CTD/eCTD formats)
Regulatory gap analysis and risk-based strategies
Support for compliance with FDA, EMA, CDSCO, WHO, and ICH guidelines
Quality Systems & Compliance Management:
Biotech-specific QMS design and implementation
SOPs, batch records, deviation/CAPA documentation
Audit readiness and mock inspections (FDA/EMA/WHO)
Validation & Qualification Services:
Equipment qualification (IQ/OQ/PQ) for biotech facilities
Cleaning validation, aseptic process validation
Process validation for upstream/downstream systems
Stability, Storage & Cold Chain Compliance:
ICH-compliant stability studies
Cold chain validation and packaging qualification
Storage condition mapping and environmental monitoring

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