BUSINESS SUMMARY:
Global Biopharmaceutical Regulations Inc., (GBR) helps an enterprise evaluate, manage and reduce regulatory compliance risk. GBR Woman Owned 8(a) firm was established in 2007.
EXPERTISE:
GBR provides managerial oversight as well as experienced subject matter experts for the entire project life cycle; or partner with the firm’s internal resources to achieve a nimble and financially responsive Quality Management System. We partner with firm to analyze data, reverse risk, implement process efficiencies and develop documentation to reflect a continuously improving organization. We help with audit of suppliers, laboratories, and manufacturing facilities. All our associates and partners have advanced degrees of relevant disciplines and also carry licenses for their area of expertise whether it is Quality Management Systems, Environment, Food Safety or Occupational Health and Safety. In addition to conformity assessment, we also review a segment of the standard to provide a preparedness report.
DIFFERENTIATORS:
- An electronic data collection, compilation and technical writing process, which reduces revisions by 7%.
- A five point Pre-audit planning that brings efficiency and reduces expense on-site presence of auditor and program manager
- Single step audit report preparation online, for immediate reporting
- Experienced/bilingual license carrying auditors capable of a more rigorous high risk project outside of US borders
- Project lifecycle management
HISTORY/MILESTONE/ACHIEVEMENT
- 2000 Registered with Secretary of State
- October 2002 Completed First Government Assignment for NIH-NIAID
- Nov 2003 Grew to 3 employee
- June 2006 Self Certified as a Small Business
- January 2007 Grew to 11 employees
- April 2007 Certified as Small Disadvantaged Business (SDB)
- March 2008 Completed Second Government Assignment -NIH-NIAID and NCI
- March 2009 Applied to qualify for SBA 8(a) status
- March 2009 Completed a project with NIH NIH-NIAID
- May 2010 Obtained 8(a) approval
- June 2010 Completed a project for Novartis Vaccine and Diagnostics
- Sept 2011 Completed a project for Dr. Reddys Laboratory
- April 2012 Obtained California Small Disadvantaged certification
- October 2014 Completed Certification as Woman Owned Business with WBEC-West
- June 2015 Office of Regulatory Affairs – FDA Awards us for outstanding leadership in public and private partnership
AFFILIATION
- Orange County Regulatory Discussion Group
Ruchika Raval is one of the Board of Directors for OCRA.
- American Society for Quality (ASQ)
Ruchika Raval is Vice Chair for Programs at the San Gabriel Valley Chapter for ASQ.
- Parenteral Drug Association (PDA)
Ruchika Raval serves on the board of directors of the Southern California chapter of PDA.
- Small Business Administration (SBA)
The SBA has approved Global Biopharm Regulations as a Small Disadvantaged Business under the 8(a) program.
- Small Disadvantaged Business (CA)
Global Biopharm Regulations has been selected as a SDB this April 2012.
- Women’s Business Enterprise National Council
Global Biopharm Regulations as applied to be recognized as a WBENC.
- Minority Supplier Development Council
Global Biopharm Regulations is a member