US FDA Certificate
Business Services · India · 1-10 Employees
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Overview
Headquarters
F/7 Shukun Plz L. G. Cor, S A Mills, Guj...Phone Number
+91 9426756555Website
www.usfda.netRevenue
<$5 MillionIndustry
ZI Rank: 1
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About US FDA Certificate
Samrat Associates is a consultancy firm based in Ahmedabad, India, specializing in US FDA certification services for various industries including food, pharmaceuticals, and medical devices. They provide comprehensive support for companies seeking to navigate the complexities of FDA regulations, ensuring compliance for successful market entry into the U.S. and other regions like the Middle East. With a team led by Dr. Abhimanyu Samrat, they offer services such as establishment registration, mock audits, and guidance on FDA inspections. Their commitment to global best practices and cost-effective solutions helps clients expand their businesses internationally.Explore more
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US FDA Certificate News & Media
GNTbm's self-developed anti-cancer new drug GNTbm-38 has obtained IND approval from the U.S. FDA for Phase I clinical trials
TAIPEI, March 5, 2026 /PRNewswire/ -- Great Novel Therapeutics Biotech & Medicals Corporation (GNTbm) (stock code: 7427) announced that its independently developed novel epigenetic immunoactivator GNTbm-38, with global rights for cancer immunotherapy, has received approval from the U.S....XellSmart Receives Fourth Consecutive US FDA & China NMPA IND Clearance for MSA-P iPSC-derived Cell Therapy
SUZHOU, China, March 2, 2026 /PRNewswire/ -- In February 2026, XellSmart Pharmaceutical Co., Ltd. (XellSmart) announced that it had secured its fourth US FDA and China NMPA clearance for Phase I/II registrational clinical trial entry with its independently developed, off-the-shelf, allogeneic, universal, iPSC-derived, subtype-specific neuron progenitor cell therapy targeting Multiple System Atrophy- Parkinsonian Type (MSA-P). This joins the previous three consecutive FDA-NMPA registrational triaUS FDA launches program to boost domestic drug manufacturing
By Ahmed Aboulenein WASHINGTON, Feb 1 (Reuters) - The U.S.Inovio announces U.S. FDA accepted BLA for INO-3107
INOVIO (INO) announced that the U.S. Food and Drug Administration, FDA, accepted the company’s Biologics License Application, BLA, for INO-3107 for review as a potential treatment for adults with RRP. The review classification designated by FDA is Standard. The FDA assigned INO-3107 a Prescription Drug User Fee Act, PDUFA, review goal date of October 30, 2026, which is the date by which it intends to take action on the application. The FDA has indicated that
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Samrat Associates is a consultancy firm based in Ahmedabad, India, specializing in US FDA certification services for various industries including food, pharmaceuticals, and medical devices. They provide comprehensive support for companies seeking to navigate the complexities of FDA regulations, ensuring compliance for successful market entry into t... Read More
