About PharmaLex US Regulatory Affairs Consulting

PharmaLex US Regulatory, based in Connecticut and having staff all along the east coast, offers reliable, flexible and efficient consulting services to fulfill all of your FDA regulatory needs. With regulatory experience that spans all product types from traditional pharmaceutical products to biologicals, we provide regulatory expertise and strategic insight. As the US affiliate to one of Europe’s largest and most trusted service providers to the pharmaceutical industry, PharmaLex US can also prepare seamless integrated US, EU and worldwide regulatory strategies for global development projects. Delivering one-stop FDA regulatory affairs consulting can result in significant synergies, smooth communication, and faster development timelines for you.

Our strength and competencies stem from the multidisciplinary background of our team. This experience enables us to draw from the combined knowledge of the whole spectrum of life sciences and take advantage of many years of building successful relationships with the FDA. In addition, our diversity provides a distinct advantage in an era when flexibility and creativity are keys to competitiveness. Our team has extensive experience in most therapeutic areas including, anti-infectives, oncology, neurology, endocrinology, women’s health including fertility, among others, and we have led hundreds of FDA meetings with successful outcomes.

Our experts understand the unique needs of both small and large pharmaceutical companies having held leadership positions in both types of organizations. We can offer you customized and individually adapted solutions, which will consider trends and factors that will have a future impact on the market access of your products.

As the US affiliate to one of Europe’s largest and most trusted service providers to the pharmaceutical industry, PharmaLex US can also prepare seamless integrated US, EU and worldwide regulatory strategies for global development projects. Delivering one-stop regulatory solutions can result in significant synergies, smooth communication, and faster development timelines for you.

Our Services include;
Regulatory Strategy and Services
FDA Meeting Preparation and Conduct
FDA Agent – Authorized Representative
CMC Services and Consulting
Regulatory Operations

For a quick reply contact PharmaLex US:
usregulatory@pharmalex.com
Phone: +1.203.415.7721

PharmaLex US is a proud member of the Massachusetts Biotechnology Council and CURE New Haven.

PharmaLex US is a proud member of the Massachusetts Biotechnology Council

 

PharmaLex US is a proud member of CURE New Haven