regulatory &
compliance
safe & high quality drugs!
Ensuring Safety, Quality, and Trust
We adhere to global regulatory frameworks, ensuring that all aspects of research, development, and production meet the standards set by leading regulatory agencies such as the FDA, EMA, and WHO. Our rigorous compliance protocols safeguard patient health while maintaining product quality and integrity.
Research & Development (R&D) Compliance
From early-stage research to clinical trials, our R&D processes follow Good Clinical Practices (GCP) and Good Laboratory Practices (GLP). This ensures that our clinical trials are safe, ethically conducted, and scientifically robust. Every step of our research is monitored by internal teams and external bodies to comply with global regulations.
Regulatory Submissions & Approvals
Navigating the regulatory landscape is a critical step in bringing a product to market. Our dedicated regulatory teams manage the submission of New Drug Applications (NDAs), Biologics License Applications (BLAs), and Marketing Authorization Applications (MAAs), ensuring timely approvals in different regions. We follow strict guidelines to meet the requirements of agencies such as the FDA and EMA, ensuring that our products are safe and effective.
Good Manufacturing Practices (GMP)
Quality is at the heart of everything we do. Our manufacturing processes comply with Good Manufacturing Practices (GMP), ensuring that every product is consistently produced under the highest standards. Regular audits by regulatory bodies and internal reviews ensure that our operations are efficient, compliant, and up to date.
Pharmacovigilance
Our commitment doesn’t stop after approval. Through rigorous pharmacovigilance systems, we continuously monitor the safety of our products post-launch. We track adverse events, update safety information, and conduct post-market studies, ensuring that patient safety remains a priority even after products reach the market.
Protecting Patient Information
We understand that the security and accuracy of health data are critical in today’s world. Our systems comply with global data protection regulations such as GDPR, ensuring that patient data is securely handled during clinical trials, research, and beyond. Data integrity and record-keeping are key components of our compliance strategy.
Global Compliance Expertise
Pharmaceutical regulations differ from one country to another, but our experienced global team ensures we remain compliant in every market we serve. Whether managing international regulatory submissions, adhering to specific import/export requirements, or implementing country-specific safety standards, we are well-equipped to handle the complexities of global operations.