We are a global consulting firm Headquartered in Boston Massachusetts USA
that provides Regulatory Affairs, Quality, Clinical and Safety services to
pharmaceutical and medical device companies worldwide to register their
product with the Food and Drug Administration (FDA) the local Health
Authority (HA)
Overview:
On January 2023, The U.S. Food and Drug Administration (FDA) has issued a proposed rule to amend color additive regulations to increase fees for certification services.
The proposed rule will implement a 10% per pound increase in color certification fees. This increase in fees is necessary to cover operating costs to ensure that the color certification program continues to operate at the high level of quality and efficiency that the industry expects.
Introduction:
The FDA has issued regulations for issuing Color Additive Certifications when used in foods, drugs, cosmetics, and medical devices must analyze samples of each batch of color additive received from a manufacturer and verify that it meets the specifications for composition and purity. Certification is performed before color additives are allowed to be used in products marketed to US consumers. Manufacturers pay fees, based on the weight of each batch, and these fees support the FDA’s color certification program.
Rules for Submission
Brochure : GRP USA Services
We are a global consulting firm Headquartered in Boston Massachusetts USA that provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical and medical device companies worldwide to register their product with the Food and Drug Administration (FDA) the local Health Authority (HA)
For information on the draft guidance and how to comment, please see the :
Color Additive Certification
Increase in color certification rates.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico & Korea.
GRP helps many life science companies register their products in different countries in compliance with local regulations.
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