Flourishing Third Party Regulatory Business

Business is booming for Third party regulatory compliance and quality assurance professionals/vendors.Moreover they are in high demand for regulatory related activities performed in Medical device industry,Pharmaceutical industry,Biotech industry,CROs.As markets are facing cut throat competition,less time to market is most important..Investors are eager to see streamlined, mistake-free production with a minimum amount of rework, which means quality is a high-level concern.Globalization leads to increased outsourcing of manufacturing of products and components overseas where different sets of rules and regulation could impact outcomes.Non compliance of medical devices and various pharmaceutical products leads to charges of fraud.Subsequently have made many medical devices and pharmaceutical companies aware of the importance and need for compliance majorly in their supply chain and offshore operations Medical device industries and pharmaceutical companies majorly outsourced their product compliance tasks to third party regulatory compliance professionals,the basic idea behind the compliance outsourcing is to make their products reach Indian and international markets without risk of non-compliance.FDA inspections have focused on supplier management; a majority of its warning letters cite companies for failing to adequately control products purchased from their suppliers Employing specialized third parties for regulatory compliance by medical device and pharmaceutical companies with specific domain regulatory expertise and well versed regulatory professionals again who excelled the particular regulatory domain can help companies successfully navigate this complexity Moreover the Indian government is introducing stringent rules and regulations,to heightened awareness within the device and product community for the importance of regulatory compliance and thus to safeguard the individual and national health Companies are hiring third party as they have potential to provide significantally tremendous value rather than performing in house regulatory activities Numerous companies pay in the range of $250,000-$300,000 to regulatory and quality control personnel for inhouse regulatory works.Instead same companies believes in paying third party consultant 20% of that amount to do the work