Our Dossier Preparation and Submission Support Services are designed to simplify regulatory approval processes for the life sciences and pharmaceutical industries. We assist organizations in preparing and submitting high-quality, compliant dossiers tailored to specific country requirements, ensuring seamless product registrations and minimizing approval Timelines.
Our Regulatory Operations Services deliver comprehensive support for the submission, publishing, and management of regulatory filings to ensure compliance with global health authority requirements. From electronic submissions to document management, we enable life sciences organizations to navigate the regulatory landscape with ease and efficiency.
Is designed to render a powerful advantage for the operation and planning of business units. Engineering supports planning resources for engineered parts, services. Kea cGMP enables the client to exercise the best methods in maintaining the internal engineering related services and facilitates to adopt a suitable maintenance services for their Plant
We provide regulatory publishing and archiving services, including formatting and hyperlinking submission-ready documents. Our fully compliant archiving ensures proper lifecycle management, while we create global and regional dossiers tailored to country-specific guidelines.
Our regulatory services for Computer System Validation (CSV) are designed to help life sciences and pharmaceutical companies achieve compliance with global regulatory requirements. With a focus on risk management, system integrity, and operational efficiency, our services provide a streamlined approach to validating and maintaining computerized systems critical to your business operations.
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
Happy clients
Finished projects
Skilled Experts
Media Posts
Completed Projects
Robotic Automation
Web Site Analyse
Clients Supoort Done
Testimonial
20K+ Satisfied Clients World Wide
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 Limites
VINS Bioproduct Limited
ORCH Laboratory India PVT.LTD
ExtroviesPrivate Limited
ISO Quality Management System