G&A Associates is an API development company specializing in providing ANDA and NDA holders with the peace of mind they need from their API supplier as they bring their products to market. Our team has years of experience in developing APIs for the regulated markets. Our strength is the ability to build compliance and regulatory requirements into our development process resulting in an efficient transition from samples, to scale up, to validation, to approval and launch. Our customers can trust that we will take care of everything for the API.
Our team is trained to not just identify compliance issues with our partners but also to offer solutions that take into account the customer, the FDA and the practical realities of the factory. This results in solutions that are feasible to implement and ensures that it complies with cGMPs. We have implemented a comprehensive compliance program based on the Six System FDA approach that routinely monitors and trains our partners to the current industry standards. At a minimum, our protocol includes audits every 6 months with increasing frequency as we prepare the factory for an FDA inspection. During the FDA Inspection we manage the inspection by providing translators trained to work with FDA. We help correct potential observations and if there is a Form 483 issued we help prepare the response. Each of our Managers have at least 30 FDA / EU inspections worth of Experience.
Each member of our team has the experience of having developed and compiled over 40 DMFs. We also have experience working closely with FDA whenever deficiencies are issued to the DMF or to the ANDA. Because we have regulatory in mind when we develop our products, we can anticipate potential regulatory inquiries from FDA and proactively address them prior to becoming a deficiency or rapidly respond to them ensuring that your approval does not get delayed.
Our aim is to make API sourcing the least difficult part of your development, your approval, your launch and your commercialization.