Interpreting and Applying the Law
Regulatory Affairs leaves no room for error. Understanding precepts in each market is just the beginning. Our RA specialists are also experts in how they apply to your product, for complete confidence.
Providing Strategic Direction
Our experts act as technical and scientific liaisons, keeping in-house departments and regulators informed and up to date. Experienced in and passionate about our work, we can advise you on tough but critical decisions to be made throughout the drug life cycle.
Directing Data for Compliance
Data compilation and statistical reporting are some of the reasons that the drug development process is so rigorous. Yet, all necessary to get the drug to market. Our regulatory experts make sure your data is done right.
How We Can Help
For every pharmaceutical, from new Rx, OTC, generic, to “other," there are countless submissions, forms and data reports to be completed, reviewed and approved. That reality is an incentive to make sure everything is done right the first time.
Informing the medical community and potential patients about a new drug therapy requires strategic planning. The FDA in the United States, Health Canada, and the EU’s MDR, along with other regulatory bodies, must control that messaging to ensure ethical and accurate information is presented, including risks.
Chemical Manufacturing and Controls, or "CMC," describes the regulations that assure a drug meets standards, labeling requirements, and intended use confirmation. CMC also serves as a quality check between clinical trial formula and the final product.
A non-industry outsider may ask, “What’s in a label?” To which every drug developer responds, “Everything.” In addition to the carton messaging, labeling regulations include many leaflets, inserts, and other statements to educate on the product.
Market conditions and your company’s strategy for launching a drug are well-informed by similar products under development by key competitors. Knowing the current position in the pipeline of a competitor product, for example, can be useful in creating your ideal timeline. Understanding clinical information and how it applies to specific markets is also valuable to your strategy.