Expert Services for the Pharmaceuticals Industry
At Smith & Burgess, we help pharmaceutical manufacturers maintain safe, compliant, and efficient operations through specialized process safety and engineering services. In an industry where precision, quality control, and regulatory compliance are paramount, we deliver solutions that safeguard both people and product integrity. Our work supports a wide range of pharmaceutical facilities, including bulk drug manufacturing, formulation plants, and biotechnology operations.
Relief and Flare Studies
Pharmaceutical processes often involve high-value materials and low-pressure systems that require precise relief system design. Our Relief and Flare Studies evaluate these systems to ensure compliance with ASME, API, and site-specific standards. We account for unique process conditions, batch operations, and sterilization cycles while validating system adequacy and preventing overpressure scenarios. Our approach minimizes product loss, environmental impact, and downtime.
- Relief Systems Analysis
- Flare Systems Optimization
- Concern Mitigation Planning
- Guidelines & Standards Development
Process Safety Services
We provide process safety services tailored to the highly regulated pharmaceutical environment. Whether you're addressing OSHA PSM, FDA guidelines, or internal safety standards, we offer PHAs, LOPAs, QRAs, compliance audits, and risk assessments that align with your operational and quality objectives. Our experts help clients build a strong safety culture while navigating complex regulatory landscapes — ensuring your teams are protected and your operations remain uninterrupted. Our approach supports compliance with both OSHA/EPA regulations and Good Manufacturing Practice (GMP) standards, helping you meet dual regulatory requirements without compromising product integrity.
Our expertise includes:
- Process Hazard Analysis (PHA)
- Quantitative Risk Assessments (QRA)
- Facility Siting
- Fire & Explosion Modeling
- Action Item Management
- PSM & RMP Audits & Assessments
- Emergency Response Planning
- Process Safety Information (PSI)
- Low-Pressure Tank Mechanical Integrity
- Specialized Studies & Modeling
- Specialized Studies & Modeling
- Management of Change (MOC)
- Incident Investigation & Root-Cause Analysis
Engineering Design Reviews
We conduct Engineering Design Reviews that focus on equipment design, facility layout, and utility systems common in pharmaceutical manufacturing. Our team evaluates P&IDs, relief system designs, and cleanroom processes to ensure safety, sterility, and operational efficiency. We support new construction, expansions, and upgrades with insight that helps streamline validation efforts and reduce rework during commissioning.
Our services include:
- Conceptual Engineering & Feasibility Studies
- Front-End Engineering Design (FEED)
- Detailed Engineering & Process Optimization
About Smith & Burgess
Smith & Burgess is a process safety consulting firm dedicated to helping clients across regulated industries operate with confidence. Our pharmaceutical expertise combines technical excellence with a deep understanding of quality and compliance. We work collaboratively with engineering, operations, and safety teams to provide actionable, scalable solutions that support product safety and operational reliability.
Global Reach, Local Expertise
Smith & Burgess serves pharmaceutical clients across the globe through our strategically located offices in Houston, Singapore, and India. These locations allow us to provide timely, region-specific support while maintaining the high standards our clients expect. Whether you're navigating FDA regulations in the U.S. or meeting global GMP and safety standards abroad, our team delivers the expertise and insight needed to ensure safe, compliant operations worldwide.