Biotechnological Industries

At FicusRealtime, 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

 

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