Welcome to the Regulatory Affairs at Primasoft Inc, where compliance meets innovation. We understand the critical role that regulatory affairs play in bringing transformative healthcare solutions to market. Our dedicated team of regulatory experts ensures that our products adhere to the highest standards, meeting regulatory requirements across global markets.
Our Regulatory Expertise
At Primasoft Inc, we pride ourselves on maintaining a deep understanding of the ever-evolving regulatory landscape. Our regulatory affairs team comprises experienced professionals with expertise in navigating complex regulatory pathways, ensuring compliance with international standards and regulations.
Global Regulatory Strategy
We develop robust global regulatory strategies tailored to the unique requirements of each market. Our experts stay ahead of regulatory changes, working closely with regulatory agencies to anticipate challenges and streamline the approval process for our innovative healthcare solutions.
Quality Management Systems
Quality is at the core of everything we do. Our Quality Management Systems (QMS) are designed to meet and exceed regulatory expectations. From product development to post-market surveillance, our commitment to quality ensures the safety and efficacy of our products throughout their lifecycle.
Regulatory Submissions
Navigating the regulatory submission process can be complex. Our team is well-versed in preparing and submitting regulatory documentation, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs), among others. We work closely with regulatory agencies to facilitate timely approvals.