The benefits of having a well-constructed Regulatory Affairs roadmap are innumerable. At ImmuneVax, we realize the value added that stands to be derived by having a rational Regulatory Affairs plan at the outset to support the enhanced passage of products to market.

ImmuneVax's main Regulatory Affairs focus is on Title 21 of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP).

In order to market products, companies must provide regulatory agencies with the specific information to prove safety and efficacy of their products. Therefore, throughout the submission assembly and review process, communication with the regulatory authority is a critical activity. To this end, we strive to build a strong rapport with Agency Regulators, and take careful note of their constructive criticism, and accordingly, are far more likely to end up in full compliance with the CFR.

ImmuneVax will provide experts with extensive industry experience in the licensing of biologic and biotech medicinal products. Whether you are a multi-national, SME, Start-Up or University, we seek to be your preferred partner. Whether you are looking for experts to discuss your Regulatory Affairs options (from obtaining Scientific Advice through to global filing strategies) ImmuneVax Life has access to experts with experience in obtaining successful submissions in all major Regulatory Affairs markets.