Antiksha Joshi's Linkedin Analytics

I am a quality systems and compliance consultant (very vanilla & generic title, I know). But let me explain why I love this boring sounding title 😊 . As a regulated industry (whether small molecules, medical devices, combination products, biologics, etc.), the main goals are: 🌟 Continued compliance to regulations (to ensure patient safety) 🌟 Increased efficiency & profitability through improved business operations 🌟 Talent retention & better employee engagement 🌟 Becoming a partner of choice for customers 🌟 On time & on budget completion of drug development projects (for faster/cheaper access to life saving treatments) 🌟 Attracting steady investments These goals are common across the type of organisation (virtual, start-up, CDMO, commercial manufacturer etc.). The priority rating may differ depending on what your business model looks like & what stage of product lifecycle you are at. Having worked with both the ISO 9001 and the Pharmaceutical Quality Systems for over 25yrs, I have learnt first-hand that QMS principles & its accompanying tools, can be used by any organisation to achieve the above goals. While the QMS elements appear generic, they can be easily customised for an organisation's specific operations & easily combined with regulatory requirements. So, this is what I help organisations do: get the most out of their business processes (digitalisation, training, audits, validations, documentation & data governance, tech transfer, risk assessments, management reviews, etc.) through customisation & simplification, all the while staying. compliant. Using this framework, I have assisted biotech startups, CDMOs and Clinical trial sites identify their compliance and efficiency gaps and implement tailored quality systems. Whether you are seeking to enhance your current systems, embark on digital transformation, or simply explore how quality systems can bolster your business operations, then let's have a chat. #life sciences #pharmaceuticalmanufacturing #digitaltransformation #training #continuousimprovement #gmp #compliance