Founded in 2005, Business Excellence Consulting Inc. (BEC) offers consulting, remediation, auditing, regulatory affairs, and training services for the FDA-regulated industry. As a worldwide leading company, BEC covers all your compliance and regulatory needs for the pharmaceutical, biotech, medical devices, combination products, APIs, and food industries.
In these pages you will find what is needed to improve your compliance and quality system in a very cost-effective and affordable way.
Our services are tailored to your specific needs. Our team of experienced FDA industry professionals (more than 100 resources, averaging 20+ years of experience) will assist you with the implementation of risk-based, robust and sustainable solutions. We will support your efforts to achieve and maintain a compliant quality system as well as educate and develop your staff to maximize their contribution to the business.
BEC provides the following:
Industries we assist
Pharma – Biotech – OTC
Medical Devices
Combination Products
Food and Dietary Supplements
API
Excipient Quality Systems
Cosmetics
Type of Services
FDA Inspection Support
Remediation and Quality Systems Compliance
Implementation for FDA industries
Risk Management
Investigation and CAPA System Support
Human Error Prevention and Reduction
Supplier Control Programs
Submissions: DMF, ANDA, NADA, 510K
U.S. Agent, Registration and Listing
ISO Certification Consulting and Support
Validation Life-Cycle
Temporary Support: backlog elimination of Investigations, CAPAs, Complaints, and Change Controls
Our value proposition is based on four elements:
- Our focus is the U.S. FDA regulated market
- Experience, Knowledge, and Expertise
- Proven Results
- Cost-effective and Affordable Services
OUR SERVICES
