2. Background
• Biopharma consulting Services, Inc. is a
Puerto Rican based company specializing
in Validation, Engineering, Quality
Assurance and General Manufacturing
Consulting Services for the
Pharmaceutical, Biotechnology and
Medical Device industry.
3. Mission
To satisfy our client’s Validation, Quality and
Compliance needs in a timely and cost effective
manner.
High-Quality is derived from the commitment,
competency and dedication of our employees.
4. Validation Services
• Validation Project • Process Validation
Management • Computer Systems
• Construction/Qualification Validation
Project Management
• Cleaning Validation
• Facility and Utility
Commissioning and • Re-Qualification
Validation • Standard Operating
• Validation Master Planning Procedures Preparation
• Process Equipment
Validation
5. Regulatory Compliance
• Vendor qualification and inspection of suppliers, contract
manufacturing and testing laboratories
• Validation and Quality Assurance Systems Gap analysis
• Training and education in cGMP, GLP and 21CFR Part 11
regulations
• Third party review services
6. Experience
• BCS validation professionals have over 30 years of combine
hands-on experience
– Pharmaceutical Plants
– API Plants
– Medical Devices
– Biotechnology
• Experienced working on highly-regulated environments
such as consent decrees and remediation initiatives either
as internal resources and/or third party reviewers.
7. Why Us?
• We have the expertise and commitment to provide
the superior service required to meet all of your
validation and compliance needs.
• Dedication to quality, personalized support, and the
success of your projects are the foundation of our
company.
• We build partnerships and prioritize teamwork to
efficiently and cost effectively provide benefit to
your company.
