CRO/CDMO

At FicusRealtime, we support Contract Research Organizations (CROs) and Contract Development & Manufacturing Organizations (CDMOs) with specialized expertise in quality compliance, validation, documentation, and regulatory readiness.

As trusted partners in the life sciences ecosystem, CROs and CDMOs must deliver reliable, audit-ready results to their clients. We ensure that these organizations maintain high standards of GxP compliance, documentation integrity, and regulatory alignment across every phase of research, development, and manufacturing.

Services We Offer for CROs and CDMOs
Regulatory & Documentation Support:
Preparation and review of SOPs, protocols, and study reports
Support for CTD/eCTD submissions (IND, ANDA, BLA, MAA)
Regulatory gap assessments and inspection readiness
Quality Systems & Compliance:
Design and implementation of robust QMS (GMP, GLP, GCP compliant)
Internal audits, data integrity assessments, and vendor qualification
CAPA management and deviation investigation support
Validation & Technical Support:
Equipment qualification (IQ/OQ/PQ) and cleaning validation
Process validation for manufacturing and analytical operations
Support for method development and validation documentation
Clinical & Manufacturing Support:
Support in technology transfer and scale-up documentation
Quality oversight during clinical trial material manufacturing
Batch review and release documentation for sponsor submissions

 

Pharmaceutical & Lifesciences Industries

Industries We Serve

Industry-Specific Software for Enhanced Quality and Compliance

Pharma
Advancing healthcare through pharmaceutical innovations.
Engineering
Precision engineering solutions for industrial applications.
Excipients
Quality excipients for enhanced pharmaceutical formulations.
Formulations
Innovative drug formulations for effective treatments.
Biologicals
Advanced biological solutions for medical and research use.
Biotechnologicals
Cutting-edge biotechnological applications for various industries.
CRO/CDMO
Contract research and manufacturing for pharma industries.
Aquatic/Poultry
Innovative healthcare solutions for aquaculture and poultry.
Agro Based
Sustainable agro-based solutions for farming industries.
Biotherapeutics
Targeted therapies for enhanced healthcare solutions.
Aquatic Medical Devices
Medical advancements for aquatic life healthcare.
Cosmetics
Beauty and skincare innovations for enhanced personal care.
Polymers
Advanced polymer solutions for diverse industries.
Agro Chemicals
Sustainable agro-chemical solutions for modern farming.
Special Chemicals
Innovative chemical solutions for industrial applications.
Drug Pellets
Revolutionary drug pellet formulations for improved delivery.
Nano Technology
Advanced nano-technology solutions for various sectors.

Testimonials

20K+ Satisfied Clients World Wide

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