Our desire to offer our clients a proven guarantee and reliability has led us to obtain several accreditations, both locally and internationally.
Approval by the Istituto Superiore di Sanità (NB0373) and Eurofins Product Testing Italy S.r.l. (NB0477) of the Quality Assurance system for the production of class IIa, IIb and III Medical Devices.
Quality Management System certified according to the standards:
“Cosmetic Products Notification Portal” (CPNP) notification pursuant to regulation 1223/2009. Production and packaging of cosmetic products.
Pressence of Quality Assurance and Regulatory Affairs units.
Approval by the Istituto Superiore di Sanità (NB0373) and Eurofins Product Testing Italy S.r.l. (NB0477) of the Quality Assurance system for the production of class IIa, IIb and III Medical Devices.
Quality Management System certified according to the standards:
“Cosmetic Products Notification Portal” (CPNP) notification pursuant to regulation 1223/2009. Production and packaging of cosmetic products.
Pressence of Quality Assurance and Regulatory Affairs units.
Our quality is recognized all around the world, let our certifications and registrations speak for us:
Halal certification issued by World Halal Authority – WHA.
N° 00028125 Certification at Grade AA applicable to Product Category 07 – Issued by LRQA ITALY S.R.L.
CMDCAS HEALTH CANADA – Manufacturing of Medical Devices. Certificate ISO 13485: 2016 No. QS1 063353 0008 issued by TÜV SÜD AMERICA INC.
FDA Registration No. 3005488444 – Manufacturing of Medical Devices (NTO, MGQ, FRO).
Cosmetic Products Registrations (MoCRA) + Drug OTC Monography Registrations
Presence of an USA Agent (Registrar Corp).
GMP Certificate issued by ANVISA (Agência Nacional de Vigilância Sanitária).
MDSAP ISO 13485:2016 Certificate No. QS6 063353 0010 issued by TÜV SÜD AMERICA INC.
Inclusion in the Medical Devices Register of the Ministry of Health for the State of Israel; approval N° 227760001.
Production site certification No. 03733C01 at the Ministry of Health of the United Arab Emirates – Production of GSL products.
GMP certificate issued by the Korean FDA – Production of Medical Devices.
Certificate No. BG22000286 issued by the Japan Ministry of Health, Labor and Welfare – Production of Medical Devices.
Certification of conformity by the “Australian Government”, TGA
AU T00004/01. Assessment by the notified body N°0805
Production site registration 24330022031497. Mexican Ministery of Health
N° 00028125 Certification at Grade AA applicable to Product Category 07 – Issued by LRQA ITALY S.R.L.
FDA Registration No. 3005488444 – Manufacturing of Medical Devices (NTO, MGQ, FRO).
Cosmetic Products Registrations (MoCRA) + Drug OTC Monography Registrations
MDSAP ISO 13485:2016 Certificate No. QS6 063353 0010 issued by TÜV SÜD AMERICA INC.
Inclusion in the Medical Devices Register of the Ministry of Health for the State of Israel; approval N° 227760001.
Take a look at the notified bodies that have accredited us due to the quality of our processes
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