Inspired By Excellence & Innovation

We offer a wide range of high quality of regulatory services.

Previous year (2019) projects and achievements

CE Marking (Class IIa, IIb, III) 18 Projects 11 Completed

US FDA 510k (Class II & III) 05 Projects 03 Completed

EN ISO 13485:2016 17 Projects 11 Completed

21 CFR 820 12 Projects 10 Completed

21 CFR 211 04 Projects 04 Completed

21 CFR 111 03 Projects 03 Completed

MDSAP 01 Projects 01 Completed

USFDA DMF 12 Projects 12 Completed

FDA Medical Device Registration 33 Projects 33 Completed

FDA Drug Establishment Registration 43 Projects 43 Completed

FDA Food Establishment Registration 132 Projects 132 Completed

FDA Cosmetic Registration 09 Projects 09 Completed

Our Experts

Soio George
Soio GeorgeTechnical Head (Medical Devices)
An regulatory professional with 24 years of pharmaceutical manufacturing, quality assurance and Medical device regulatory consulting experience. Based in Bangalore, India.
Manoj Zacharias
Manoj Zacharias President
More than 12 years of experience in FDA compliance and registrations. Acting US Agent for more than 2000 plus firms across the Globe.
Mr. Joe Kumar
Mr. Joe KumarTitle 1
15 plus years experience in Medical Device trading in European Economic Region. Through knowledge in Vigilance and QMS. Acting as European Authorized Representative for more than 300 plus firms across the Globe.
Mr. Luke Fernandaz
Mr. Luke FernandazTitle 2
An allrounder in Medical Device regulation and trade in UK and EEC. 10 plus years experience in Medical Device Industry. Acting as UK responsible person for international manufactures. Based in London.
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