We'd like you to understand how we deliver our services. Our processes outlined here showcase the typical stages that we follow. The process details are highly customisable to clients' needs.
QUALITY MANAGEMENT SYSTEM CONSULTANCY
Our consultants bring on board years of experience of review of simple to most complex QMS. We perform a structured GAP analysis of the existing system and provide insights on your existing systems compliance to regulatory requirements. Our tool ArkAnalyze is a highly customizable tool that we use to assess the compliance of the QMS in question against many drug regulatory authority requirements, ISO requirements and other competent authorities.
CLINICAL QA CONSULTING
A specialized consulting service focused on your needs within Clinical Quality Assurance. Our experts come with rich ‘on the ground work experience’ which helps in getting up to speed with your project requirements in a short span of time. Quality Risk Assessment, Audit plan development and Assessments of deviations are some of the examples of projects successfully completed by our expert team.
Our regulatory experts come with experience form various geographies and have dealt with most major competent authorities. Their keen eye to detail can assess your current situation within the developmental life cycle more accurately. Our team at RA thus far has provided regulatory strategies with varied degrees of complexities. We at RA believe in the concept that each situation is unique and are accordingly geared to provide customized regulatory road maps for your developmental product/program.