Regulatory Affairs

Recent advances in science and technology, and an increasing focus on drug safety have put regulatory affairs at the center of the development of new therapies, drug products and medical devices around the world. Concurrently, the passing of the era of blockbuster drugs mandates that pharmaceutical companies focus on products with smaller Return on Investments (ROIs), increasing the importance of efficient development and manufacturing, two critical components of the regulatory affairs realm.

The PKNM Solutions team can help develop and implement a clear development and regulatory pathway for the most innovative and complex pharmaceutical and biotech products.

Our emphasis is on consulting relating to quality, nonclinical and clinical aspects, both from the perspective of development strategy and regulatory requirements. PKNM Solutions has the knowledge and experience to assist at all stages of product development, from conception to registration, and beyond.

With regulatory agencies, we have been working to compare “trial populations” with the real world population because of their concerns about post-approval risk.