Regulation & Validation

Baran is highly experienced in coordinating engineering, GMP and validation requirements from project inception to completion. Our experience and expertise ensure effective and efficient process management throughout the design, procurement, construction, commissioning, and validation phases.

Regulatory Services
Navigating through the FDA maze, drawing on an established network.
Baran is highly familiar with the rules, regulations and requirements involved in issuing approvals from the FDA and regulatory bodies in other countries. We provide the expertise through a range of regulatory and validation consulting services.
Catering to start-ups as well as new projects and facilities, we provide a critical link between engineering regulations and project progress. We review regulations such as the 21 CFR (Code of Federal Regulations), in particular Part 11, and adapt it to GMP (Good Manufacturing Practices) and validation practices based on official FDA and other regulatory guidelines. The outcome - more efficient design, procurement, construction, commissioning and validation processes.

Ongoing projects also benefit from our extensive experience in regulatory and validation issues. We provide a comprehensive range of services to ensure ongoing project success including:
• GMP audits
• Clean utilities design
• Cleaning validation
• Compliance auditing
• Computerized systems validation
• Expert consultation sessions