Ground Zero Pharmaceuticals (GZP) is expanding its capabilities to provide services for biosimilar development, drug or biologic/diagnostic device, and personalized medicine programs for FDA and EMA review. GZP’s CMC offers pharmacology/ toxicology, clinical and regulatory experts to help companies navigate the complexities of biosimilar programs, such as associated planning and execution of nonclinical and clinical programs.
GZP has been working with clients to develop and test prognostic/diagnostic devices and methodologies, including genetic testing and identification of biomarkers, for use during clinical trials and post-approval therapy. The company has increased its global client base across therapeutic areas such as oncology, ophthalmology, and endocrine disease. GZP has created and submitted INDs and facilitated meetings with the FDA.
Dr. Evan B. Siegel, GZP’s chief executive officer, said, “We are pleased that firms are still generating promising diagnostic and therapeutic products in the biotechnology and pharmaceutical spaces. Our clients believe that data speak strongly to regulators and we provide sophisticated and intensive help towards that end. The continued success of our business is attributable to our long-term clients, repeat business, and referrals, as well as the stability of our team. This provides an integrated and client-specific approach to delivering the highest quality regulatory and product development services.”