consulting

CONSULTING AND SERVICES
For the following businesses

Quality Systems
CE conformity marking
HACCP
Validation of sterilization process
Validation of Cleaning and in Clean Areas processes
Process Improvement
Procedure Improvement
Education and Training
Audit compliance with quality policy, procedures and work instructions

Medical Device and Cosmetic Industries
Medical Laboratories
Hospitals and Medical Clinicals
Educational Institutes
Food Industries
Plastic and rubber Industries

BIOCHEM Consulting: Your Resource for QA Help

We specialize in independent helping small/medium businesses and start-up companies obtain compliance certification to the ISO 9000, EN 46000 Standards, EU Medical Device Directive (93/42/EEC), or to ISO 13485/13488 for FDA cGMP Quality System Regulation.

You can rely on our real knowledge of reference normatives laws and manufacturing processes

Our knowledge was achieved during several years of cooperation with UNI and IMQ

Further Services

Health (CDRH) of the U.S. Food and Drug Administration (FDA).
Preparation of clinical research protocol and Investigational Device Exemption (IDE) submission.
Premarket Approval (PMA) application.
Premarket Notification [510(k)] submission.
Response to FDA 483 and/or Warning Letter

Biochem
Provide prompt and efficient service to the client before and beyond the point of sale.

Cost Efficiency
Due to our extremely productive staff and team purchasing approval, we are able to maintain competitive pricing and high value for our customers.

info@biochem-bcm.com

Medical Device and Cosmetic Industries

Medical Laboratories

Hospitals and Medical Clinicals

Educational Institutes

Food Industries

Plastic and rubber Industries