Securing a Brighter Future for Life Sciences
Biomedical Regulatory Institute was founded in 2001 by late Dr. Sandy Weinberg as a validation and regulatory consulting services organization. Today we provide a wide spectrum of expert services for our customers in the federal government, pharmaceutical, biotech, medical device, and laboratory instrument industries. Our engagements range from short-term projects to major regulatory undertakings.
ORGANIZATION PROFILE
Biomedical Regulatory Institute is a service organization committed to satisfying the regulatory compliance needs of our clients in the field of life sciences. We offer a comprehensive portfolio of services to help our customers maximize their marketing and sales potential.
Our Services
Every solution we provide is built on a robust foundation of quality and intimate knowledge of the regulations governing pharmaceutical manufacture worldwide thereby enabling our clients to pursue commercial success while satisfying complex requirements and guidelines enforced by the regulatory authorities.
Our Values
Integrity, Client Focus and Quality are the values that form our common base and are important components of our organization’s culture. These values permeate our way of working. We strive to maintain a leading position in these areas.
- FDA Registration for Medical Device Companies
- FDA 510(k) for Medical Devices and IVDs
- FDA Medical Device Premarket Approval
- Computer System Validation
- 21 CFR Part 11 Implementation
- Risk Assessment & Mitigation
- Equipment Qualification
- SOP Development and Review
OUR EXPERTS
Our consultants and subject matter experts have the extensive knowledge, access to a network of global staff of associated professionals and advisors, as well as key regulatory contacts necessary to succeed in the execution of any type of regulatory project.
