Kea cGMP ERP – Powering Digital Transformation in Pharmaceutical & Life Sciences Manufacturing

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

 

Pharmaceutical & Lifesciences Industries

Industries We Serve

Pharma

Intelligent, customized KeacGMP solutions for seamless FDA and global regulatory compliance.

Engineering

Precision-driven ERP and validation solutions to optimize industrial engineering workflows.

Excipients

Streamlined quality management and compliance tools for excipient manufacturers.

Formulations

Innovative formulation lifecycle management for accelerated drug development and approvals.

Biologicals

End-to-end cGMP and validation support for advanced biological product manufacturing.

Biotechnologicals

Cutting-edge digital solutions to drive biotech innovation and regulatory adherence.

CRO/CDMO

Comprehensive compliance and operational tools for contract research and manufacturing excellence.

Aquatic/Poultry

Smart solutions for sustainable aquaculture and poultry health management systems.

Agro Based

Digitized agro-based solutions ensuring sustainability and regulatory compliance.

Biotherapeutics

Tailored QMS and validation frameworks for next-gen biotherapeutic advancements.

Aquatic Medical Devices

Advanced compliance and tracking solutions for aquatic healthcare innovations.

Cosmetics

Robust GMP and regulatory tools for safe, compliant cosmetic product launches.

Polymers

Integrated quality and process optimization solutions for polymer manufacturing.

Agro Chemicals

Sustainable compliance and validation services for modern agrochemical solutions.

Special Chemicals

Customized validation and quality assurance for specialized chemical applications.

Drug Pellets

Precision-engineered solutions for innovative drug pellet formulation and delivery.

Nano Technology

Future-ready validation and compliance frameworks for nanotechnology breakthroughs.

Testimonials

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