Regulatory team at Abinopharm, Inc. offers consulting on GRAS and Self-Affirmed GRAS for Nutraceuticals, DMF for active pharmaceutical ingredients, ANDA/505b2/NDA/BLA for drug products

The regulatory team at Abinopharm, Inc. offers a comprehensive suite of regulatory services, including:

Nutraceuticals and Dietary Supplements:

  • US FDA Generally Recognized as Safe (GRAS)

  • Self-Affirmed Generally Recognized as Safe (SA-GRAS)

  • US FDA New Dietary Ingredient (NDI)

  • Canadian Natural Product Number (NPN)

Generic and Modified Generic Drug Products:

  • US FDA Abbreviated New Drug Application (ANDA)

  • US FDA 505(b)(2) New Drug Application (NDA)

  • Canadian Abbreviated Drug Submission (ANDS) for both generic and modified generic drug products

New Drugs:

  • US FDA New Drug Application (NDA)

  • Canadian New Drug Submission (NDS)

Biologics:

  • US FDA Biologic License Application (BLA) and Biosimilars

  • Canadian New Drug Submission (NDS) for new biologics and biosimilars

Let’s Work Together

If you are seeking a partner to prepare and file any of the above dossiers, or if you have any questions regarding these applications, please do not hesitate to contact us. We are committed to being your most reliable, knowledgeable, and cost-effective partner for these regulatory filings and approvals.