Our tale begins in the vibrant mid-eighties, where my career in pharmaceutical development and validation took flight. It was during this prolific period that I was privileged to contribute to the birth and commercialization of five significant drug products. This era bestowed upon me a wealth of knowledge about the intricate science and stringent regulatory requirements necessary to evolve a concept into a commercial, safe, and efficacious pharmaceutical product capable of addressing specific medical needs.
Fast-forward to 2011, the year I channeled my accumulated expertise into establishing a consulting firm dedicated to delivering scientific, technical, and regulatory compliance services. By 2014, our services became pivotal in assisting a major pharmaceutical company in resolving a warning letter from the FDA. Our involvement included validating and documenting a multitude of analytical test methods, in addition to providing comprehensive training on these methods. This endeavor was met with resounding success, enabling the client to resolve the warning and refocus on their core business.
However, the substantial costs associated with this resolution prompted an introspective question: How would smaller, medium-sized pharmaceutical companies cope if they found themselves in a similar predicament? The likely outcomes were disheartening – either they would cease operations or succumb to acquisition by a larger entity.