ISO 9001; ISO 13485 and prepare associated scientific documents
Reduces Costs and Avoids Delays Right Before Market Launch with Continuous Preparation for Inspection Readiness.
Audit and Gap Analysis
Prevent Delays with Periodic Check of Internal Processes and Supplier Base.
Allocate Resources Judiciously with a Strategic Plan for Regulatory Filing.
Scientific and Technical Writing
Reduce Deficiency Letters from Agency Through Clearly Written, Well Summarized Technical Information.
About GBR Inc
Global Biopharmaceutical Regulations Inc., (GBR) helps an enterprise evaluate, manage and reduce regulatory compliance risk. We partner with our Client 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.
ISO 9001; ISO 13485; ISO14644
Auditing/Gap Analysis for GMP Compliance
Pre-approval inspection preparation
Prepare/Stage Document, Rehersal with Subject Matter Experts
Changes to Manufacturing Process During Clinical Trials and Post Market Launch
Preparation towards Regulatory Agency inputs