Why Regulatory Services Are Important In Clinical Trials?
Pharmaceutical and the clinical trial industry are the most regulated amidst all other industry verticals. Therefore, every drug priority to attaining market approval needs to undergo strict scrutiny and clinical trials. This ensures its efficacy, safety and quality. These standards of scrutiny and assessment are generally established by regulatory authorities of their respective countries, for instance Medicine Control Agency (MCA) in UK, Drug Controlling Authority (DCA) in India, FDA in US and many more. The monitoring practices by the pharmaceutical regulatory authorities continue even after the drug has been sanctioned post the clinical trials and marketed in order to detect whether there is any harmful side effect when used by the mass. Clinical regulatory services and policies therefore, have a crucial role to play in catering to the regulatory standards. These services cover the activities which help to create evidence that proves that a medical drug is safe and it meets the legal standards, thereby ensuring good health of the people at large, Clinical regulatory services help in drug development procedures from clinical trials, marketing phase to post approval practices. It acts as a primary link between the company and the regulatory agencies. A regulatory service professional is accountable for keeping up pace with the increasing complexity as well as the scope of the regulatory policies and services. They act as the main interpreters of law and regulation for other members. Regulatory services along with quality assurance form an integral aspect of the entire service portfolio in most clinical research organizations (CRO) today. There is a specialized team dedicated to regulatory services and audit compliance that are in turn supported by an in-depth clinical know-how of the local regulatory processes and meaningful alliance with multiple regulatory agencies, making sure there is efficiency in the clinical trial approval process. The service portfolio comprises the following: * Formulating regulatory strategies * Compiling clinical trial applications * Managing the submission and follow-up of the clinical trial application * Responding to regulatory agency enquiries * Procuring drug import licenses * Safety reporting * Tracking approvals and applications * Renewing the Import licenses * Managing the submission of the Clinical Safety Report (CSR) * Procuring NOC for the export of biological samples Today the regulatory service department in most Indian CRO’s has the experience of multiple audits of the Indian and global regulatory agencies. They also have experience in making study submissions to various countries and have been approved for the same in places such as in MOH Israel, NPCB Malaysia and National Medicines & Poisons Board, Republic of Sudan. Read More About: Biometrics Companies, Bioavailability, Clinical Pharmacokinetic