Regulatory Consulting

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.

CSV

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.

Assessment

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.

Data Integrity solutions

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.

Validation Report

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.

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.

Our Empowered Clients

Testimonials

20K+ Satisfied Clients World Wide