End-to-End Product Lifecycle Support FRT delivers comprehensive regulatory strategy, compliance, and submission expertise for pharmaceuticals, biologics, medical devices, and in vitro diagnostics (IVDs). We partner with clients to navigate global regulatory frameworks, accelerate market access, and ensure sustained compliance across all stages of development, approval, and post-market management.
Ficus Realtime: Precision-Driven CSV Solutions for Compliance – Ensure FDA 21 CFR Part 11, EU Annex 11, and global compliance with risk-based validation, end-to-end system validation (LIMS, ERP, MES, IoT/cloud), and audit-ready documentation. Maintain system integrity with proactive monitoring, change control, and automated validation lifecycle management (ALM) tools.
Data integrity refers to the accuracy, consistency, and reliability of data throughout its lifecycle. Ensuring data integrity is crucial for organizations, especially those in regulated industries such as healthcare, finance, and pharmaceuticals. Here are some common data integrity solutions and best practices that organizations can implement.
Adhering to GDPR and HIPAA ensures the protection of sensitive data through strict guidelines on collection, storage, and processing. Encrypted documentation and storage solutions secure data by making it unreadable to unauthorized users, safeguarding privacy and ensuring compliance.
We use top-tier tools like ValGenesis and Kneat for validation, alongside testing frameworks such as HP ALM, Jira, and Selenium to ensure efficient and accurate system performance.
Intelligent, customized KeacGMP solutions for seamless FDA and global regulatory compliance.
Precision-driven ERP and validation solutions to optimize industrial engineering workflows.
Streamlined quality management and compliance tools for excipient manufacturers.
Innovative formulation lifecycle management for accelerated drug development and approvals.
End-to-end cGMP and validation support for advanced biological product manufacturing.
Cutting-edge digital solutions to drive biotech innovation and regulatory adherence.
Comprehensive compliance and operational tools for contract research and manufacturing excellence.
Smart solutions for sustainable aquaculture and poultry health management systems.
Digitized agro-based solutions ensuring sustainability and regulatory compliance.
Tailored QMS and validation frameworks for next-gen biotherapeutic advancements.
Advanced compliance and tracking solutions for aquatic healthcare innovations.
Robust GMP and regulatory tools for safe, compliant cosmetic product launches.
Integrated quality and process optimization solutions for polymer manufacturing.
Sustainable compliance and validation services for modern agrochemical solutions.
Customized validation and quality assurance for specialized chemical applications.
Precision-engineered solutions for innovative drug pellet formulation and delivery.
Future-ready validation and compliance frameworks for nanotechnology breakthroughs.
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
VINS BIOPRODUCTS LIMITED
ORCH LABORATORIES INDIA PVT.LTD
EXTROVIS PRIVATE LIMITED
ISO QUALITY MANAGEMENT SYSTEM
NSJ PRAYOG LIFE SCIENCES PVT.LTD
CERTIFICATE OF EXCELLENCE - KeacGMP & CSV
