Regulatory affairs is
a critical part of drug development, where a successful outcome of a sound regulatory strategy is an approved
product. Having a regulatory strategy in place early in the development process can often prevent surprises later that
can hinder a successful application. Oftentimes, the regulatory requirements for chemistry, manufacturing
and controls (CMC) are overlooked until too late in the development process. For example, as safety is a
primary focus for early clinical studies, adequately addressing this aspect from a CMC perspective during early toxicology
studies can help strengthen an application for an investigative study, thereby reducing the chances for a clinical
hold. Likewise, certain aspects of clinical development, such as bioavailability, are also integrally related to CMC.
Our goal is to ensure that all aspects of regulatory affairs, including CMC and
its relationship to other disciplines, are considered early and proactively in the drug development process. We strive to partner with your organization, using strong interpersonal
and teamwork skills, while applying our expertise and years of experience to your project. We specialize in coordinating regulatory
strategies that maximize your chances for success with regulatory agencies around the world.
Have a strategy in place but just need the manpower to prepare your
submission documents? We can do that too. Our consultants have years of technical writing experience and can
work with your employees to provide documents that meet the needs of your organization, but also are in line with
current global regulatory expectations. Our writing reflects an excellent attention to detail, particularly with regards to data accuracy and
adherence to regulatory guidelines and industry practices.
If we don't have the answer, we will find it for you. We have extensive contacts with
other regulatory affairs specialists and pharmaceutical development experts. If we can't provide the services
you need, chances are we can recommend someone who can.
Find out more About Us, then look at our Services to make your possibilities a reality.