Are you prepared to produce your PET drugs according to the new FDA CGMP guidelines? As of December 9, 2011, all producers are required to register as a manufacturer, submit a New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA), and obtain FDA approval to market in the U.S., or have a plan in place to do so.
Biologics Modular can get you FDA-ready. Well provide you with a CGMP-compliant manufacturing facility that is pre-constructed and pre-tested to industry guidelines using intermodal shipping containers as the building blocks. The ISO 8, 7, and 5 cascade needed to produce clinical material can be engineered and manufactured in a matter of weeks and installed on your premises over a weekend.
Additionally, stray radiation can be easily mitigated by welding lead plates to the exterior structure, blocking emissions.
Biologics Modular has the relationships to qualify and validate the process, establish the necessary quality controls for CGMP production of clinical material, and provide the regulatory strategy and support you need to be successful.
