Regulatory Project Management Support

We coordinate and oversee all regulatory activities to ensure compliance with industry standards and timely submission of required documents. These services include planning, documentation management, compliance monitoring, and acting as a liaison with regulatory authorities. This support helps streamline the regulatory process, reducing risks and ensuring efficient market entry for pharmaceutical products.

Drug Development Regulatory Support

We understand that each drug development program presents unique challenges, and we are dedicated to addressing these challenges with precision and expertise. At Agilix, our regulatory experts bring extensive experience in managing regulatory aspects of drug development.

Our tailored offerings are designed to effectively manage critical developmental issues, ensuring that regulatory requirements are seamlessly integrated into your development process. By employing a proactive approach, we focus on mitigating risks, streamlining regulatory processes, and expediting timelines.

QMS & Audit Support

Quality Management System (QMS) & Audit Support at Agilix ensures your operations meet regulatory standards and maintain high-quality performance.

This integrated service includes:

• QMS Implementation: Developing and maintaining robust quality management systems tailored to your needs.

• Internal Audits: Conducting thorough internal audits to identify and address compliance gaps.

• Regulatory Audits: Preparing for and supporting regulatory inspections to ensure successful outcomes.

• Continuous Improvement: Providing ongoing support to enhance your QMS and maintain compliance.

GxP Services

At Agilix, we provide comprehensive GxP services to ensure your pharmaceutical products meet the highest standards of quality, safety, and compliance. Our expertise spans across Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP), ensuring that every stage of your product’s lifecycle adheres to stringent regulatory requirements.