Regulatory | Quality | Clinical
The rise of complex technologies and constant changing of regulatory environment, regulatory professionals in the Medical Device Industry are facing more challenges. In addition to keeping up with these changes, regulators must also define the correct pathway for incoming registered products. We have a global presence with teams of local experts who can develop the appropriate regularly intelligence, strategy and pathway for the registration of your device in different markets.
Having the appropriate Quality Management System in place and complying with Good Manufacturing Practices (GMP) requirements or with ISO 13485 requirements is mandatory for both pharmaceutical companies and medical device companies before getting their products approved by health authorities. Additionally, pharmaceutical and medical device companies must maintain the same quality management system during the whole lifecycle of their products. Many pharmaceutical and medical device companies encounter many challenges during the implementation and or maintenance of the required quality management system due to luck of expertise or shortage in resources. Nova Clinical Solutions, Inc. Quality Team has the required skills , experience and certifications to assist pharmaceutical and medical device companies develop the required quality standard operating procedures (SOPs), implement and maintain the appropriate quality management system to be in compliance with GPM or ISO13485 requirements through the whole products cycle. GRP Certified Quality Auditors can help you prepare for FDA inspections and response.
Our professionals apply their therapeutic, regulatory, and operational expertise to consistently make sure that your clinical studies are conducted with ICH guidelines and other applicable regulatory requirements. In an increasingly challenging environment, we have the experience and knowledge to find, recruit, and retain patients in clinical trials. We successfully deliver access to appropriate sites and patients, developing strategies that will minimize the risks inherent in-patient recruitment.