Services

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"Bridging the gap between biotech manufacturing and Regulatory Agency" services includes comprehensive, end-to-end process support, and quality management for your CMC/IND approval and ISO compliance efforts so you can focus on  drug discovery, development and manufacturing in the advancing the field of biologic medicine and therapies.  That's how together, we ensure your success.

• CBER could be moving from "no response" warning letters to delivering up to $50K in fines for finding unapproved products sold or exported in the US.
• The decrease of the COVID pandemic should increase more CBER resources dedicated to this giant cell therapy mess.
• CBER has assigned an Office of Biological Products Operation - Division 2.  They are ramping up regional FDA Compliance Officers.

• We know how to move your products through these complex approval processes.
• The is still the opportunity to have one of the first FDA and EMA approved products in the US and European marketplace.
• For unregulated countries, ISO compliance is gaining more popularity, is recognized for product commercialization and is also mandatory in the EU

Your need someone on your side who knows how to accomplish the unthinkable!