Pioneering Excellence
in Life Sciences
Regulatory Solutions
Sailax Pharma is a leader in the life sciences industry, delivering cutting-edge solutions in regulatory affairs, pharmacovigilance, and quality assurance. Our expertise spans intellectual property rights (IPR), Good Manufacturing Practice (GMP) compliance, toxicology solutions, and advanced regulatory intelligence tools, including our proprietary Regulatory Information Management System (RIMS) and AI-driven Regulatory Intelligence platform.
We are committed to empowering life sciences organizations to achieve seamless market access, enhance revenue growth, and maintain compliance throughout the product lifecycle—from early development and regulatory submissions to post-market surveillance and lifecycle management.
What We're
All About
Our Core Offerings
We provide comprehensive, end-to-end solutions to meet the diverse needs of the life sciences industry
Regulatory Affairs
Expert guidance on global product registrations, preparation of CTD/eCTD dossiers, and lifecycle management to ensure compliance and market readiness.
Pharmacovigilance
Robust adverse event monitoring, PSUR/DSUR submissions, risk management plans, and post-marketing surveillance to uphold drug safety standards.
Quality Assurance
Comprehensive GMP, GDP, GCP, and GLP audits, inspection readiness, Standard Operating Procedures (SOPs), and Quality Management System (QMS) implementation.
Intellectual Property Rights (IPR)
Strategic support for protecting and managing intellectual property throughout the product lifecycle.
Toxicology Solutions
Expert toxicological assessments and risk evaluations to support regulatory submissions and product safety.
Regulatory Intelligence Tools
Our advanced Regulatory Information Management System (RIMS) and AI-driven Regulatory Intelligence platform provide real-time insights and streamlined compliance processes.
Why Choose Sailax Pharma?
We are committed to providing the best pharmaceutical services with a focus on quality, reliability, and customer satisfaction.
Global Expertise
Proven experience navigating regulatory requirements across major markets, including USFDA, EMA, Health Canada, CDSCO, and WHO.
Innovative Technology
Leveraging our proprietary RIMS and AI-driven platforms to deliver actionable regulatory intelligence and streamlined workflows.
Tailored Solutions
Customized strategies aligned with your product, market, and compliance objectives.
Commitment to Compliance
Ensuring accuracy, quality, and regulatory adherence at every stage of the product lifecycle.
Global Reach
Supporting clients in both established and emerging markets worldwide.
Industries We Serve
Sailax Pharma proudly serves a wide range of life sciences sectors, including:
Pharmaceuticals
(Innovator and Generic)