Weinberg Group

Weinberg Group is a global pharmaceutical and regulatory affairs consulting firm that provides strategic advice and practical assistance to the biotechnology, pharmaceutical, and medical device industries. The firm was established in 1983 by Dr. Myron Weinberg, a renowned expert in the field of pharmaceutical regulatory affairs.

History[edit | edit source]

The Weinberg Group was founded in 1983 by Dr. Myron Weinberg, who had previously served as the Director of the Food and Drug Administration's (FDA) Division of Biological Investigational New Drugs. The firm has since grown to become a leading provider of regulatory and compliance services to the pharmaceutical, biotechnology, and medical device industries.

Services[edit | edit source]

The Weinberg Group offers a wide range of services to its clients, including:

Regulatory Strategy: The firm provides strategic advice on the development and implementation of regulatory strategies for new and existing products.
Clinical Trials: The Weinberg Group assists clients in the design and execution of clinical trials, including the preparation of Investigational New Drug (IND) applications and New Drug Applications (NDAs).
Quality Assurance and Compliance: The firm offers services related to quality assurance and compliance, including Good Manufacturing Practice (GMP) audits and Quality Management System (QMS) implementation.
Post-Marketing Surveillance: The Weinberg Group provides post-marketing surveillance services, including Pharmacovigilance and Risk Management Plans (RMPs).

Clients[edit | edit source]

The Weinberg Group serves a diverse range of clients, including large multinational pharmaceutical companies, small biotechnology firms, and medical device manufacturers. The firm's clients span the globe, with a significant presence in the United States, Europe, and Asia.