Passion for Quality

Business Excellence Consulting was founded in 2005 and our experience has been focused on providing worldwide valuable services to the FDA regulated industry.

More About Our Company

Our Value Proposition

Our focus is the U.S. FDA regulated market. We provide cost-effective and affordable services with the experience, knowledge, and expertise that have demonstrated proven results to our customers.

Quality and Knowledge

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.

Our Publications

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

Training and Education

Auditing and Assessment

Remediation and Quality Systems Compliance

Data Integrity

Implementation for FDA industries

Risk Management

Investigation and CAPA System Support

Human Error Prevention and Reduction

Supplier Control Programs

Outsourcing Activities

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