Brighton Ashford

Pharmaceutical & Medical Device Consulting

21 USC §§355(b),(i),&(j), and §360(k) & 360e CMC Regulatory Compliance


Whether you are investigating the safety and effectiveness of a pharmaceutical, a medical device, or a combination product you are required to submit information to regulatory agencies, including the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA), describing the methods used in, and the facilities and controls, and see, used to ensure the quality of your product.

Your regulatory submission will balance on your compliance with established performance standards, including those established by the United States Pharmacopeia (USP), the European Pharmacopeia (EP), and the International Council on Harmonization (ICH), among others (see, BPOG, PQRI).

Execution of these USP, EP, and ICH performance standards in a lab that complies with current good manufacturing practices (cGMP) will be key in assuring the quality of your FDA or EMA application's foundation.

We at Brighton Ashford have extensive experience in guiding clients through the cGMP testing required, including stage appropriate assay and impurities method development & validation, extractables & leachables testing, stability studies, and microbiological testing required to meet these performance standards.

If you would like to learn more about how Brighton Ashford can help you navigate the regulatory landscape and build a better foundation for your regulatory submission, please schedule a free 30 minute initial consultation here.

On your journey to the marketplace, let us help you navigate the vast sea of pharmaceutical and medical device regulations.