Complete adherence to regulatory compliance guidelines and GMP is fundamental to
everything we do at Pelltech Healthcare. This helps us create apex quality products to address the needs of our partners. Our manufacturing facility is integrated with a comprehensive quality management system (QMS) which ensures compliance with applicable quality regulations, codes, standards and industry best practices.
Our teams are accountable to monitor and maintain the quality during research, design,
manufacturing, and service levels. Quality Control (QC) and Quality Assurance (QA), act as our strengths and key differentiators in ensuring the high standard of our operations.
At Pelltech Healthcare, the enhancement and continuous improvement of quality is the responsibility of every individual. As part of our intent focus of our customers’ compliance needs, we track new regulations and monitor and implement new regulatory trends.
Our team has a depth of pharmaceutical and project management experience. We have both empathy and
authority when it comes to our clients’ points of view. We prioritize our commitment to quality because we’re 100% in agreement with its utmost importance in our industry.
Quality comes through transparency and commitment. We’ve earned the trust of clients around the world
and collaborate with them to deliver the best products to patients.
Clients depend on and demand uncompromising quality. Our approach is to continuously devote ourselves to betterment. This means pursuing improvement across every functional area of our business and being proactive in problem-solving.
Understanding the science and engineering behind the process of manufacturing is key to improving the actual quality of our processes. In cooperation with our customers, we focus on determining the critical quality factors that impact each and every step of the production process.
By building quality into and across manufacturing processes, we achieve a uniform and sustainable quality performance. Our main focus is the elimination of the sources of process variability.
Method Development And Validation
Dissolution And Drug Release profiling
Cleaning Validation
Stability Testing As Per ICH guidelines
Release testing
In-process production support