Ficus Realtime

Drug Intermediates

Ensuring Regulatory Compliance and Quality in Intermediate Manufacturing
At Ficus Realtime, we offer specialized support for pharmaceutical companies engaged in the manufacture, validation, and compliance of drug intermediates.As a critical component in the Active Pharmaceutical Ingredient (API) production chain, intermediates must be produced under controlled conditions, with strict adherence to GMP and global regulatory standards.

As a critical component in the Active Pharmaceutical Ingredient (API) production chain, intermediates must be produced under controlled conditions, with strict adherence to GMP and global regulatory standards.

Our Services Cover:
GMP Compliance for Intermediates:
Implementation of ICH Q7-compliant practices
Controlled environment and process documentation
Quality risk management and deviation handling
Validation & Qualification Support:
Process validation for intermediate stages
Cleaning validation of equipment and production lines
Analytical method validation for in-process testing
Documentation & Quality Systems:
Batch Manufacturing Records (BMR) and logbooks
Change control, CAPA, and deviation management
SOP development and lifecycle maintenance
Regulatory & Supply Chain Readiness:
DMF/CTD documentation support for regulated intermediates
Vendor and raw material qualification
Audit preparedness and gap assessments

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