The key to high caliber industry performance is to have a strong Quality System in place.

BioStar offers our services to help you with your Quality Systems Development and Implementation, Design Change Control Systems, Product and Process Control, Product Development, Process Automation and Methods Improvement, Risk Management, and Sigma Six Analysis.

Audits can help your company identify product line deficiencies before they grow into major stumbling blocks and become cumbersome, time consuming and expensive to fix.

We provide GMP and QS Regulation Compliance Audits, GLP and GCP audits, Design Control audits, and Clinical study audits and can perform Simulated audits to help you prepare and be responsive during the actual audit from regulators.

In today’s world of ever changing and ever expanding regulations, it is vital that your company is proactive in making sure that product lines are in compliance.

BioStar can provide guidelines to assure Regulatory Compliance (QSR, ISO, EU) and perform Compliance Audits, QA/QC Development, Validation and Generation/Development/Review of SOPs, On Market Product Maintenance and Monitoring, CAPA, and Gap Assessments.

Let us help you navigate through the complex world of FDA approvals and submissions.

We can help with FDA Submissions and Response, FDA Warning Letter Response and Action Strategies, due diligence and feasibility evaluations, Pre-market Notifications [510(k)], Investigational Device Exemptions (IDEs), Pre-market Approval Applications (PMAs), and Investigational New Drug Applications (INDs)

Employees must fully understand the requirements of the regulations that guide how your company produces product and validates reagents and protocols in order to be sure that all aspects of manufacturing are in compliance.

BioStar offers training programs for employees in QS Regulations, GMPs, GCPs, and GLPs.

BioStar can help you generate and/or refine those critical documents, prepare manuscripts for publication in peer-reviewed journals or help you obtain grant funding through assistance with grant applications and submissions.

We can provide assistance with Generation and Development of SOPs, Manuscript preparation and submission assistance and assistance with Grant application preparation.