EH&S and Regulatory

We can provide a wide range of environmental, health and safety, and quality services to support both project design and ongoing facility operational needs. We can provide regulatory compliance support including development of compliance programs, environmental permitting, process hazard analysis, pollution prevention, and Current Good Manufacturing Practices (cGMPs).

Services Include

  • Regulatory compliance systems and procedures
  • Waste minimization and pollution prevention programs
  • Air emissions estimation and facility permitting
  • Wastewater and stormwater management and permitting
  • Hazardous and industrial waste management
  • Incident investigation
  • Process hazards analysis
  • Process safety evaluation
  • Utility system recommissioning for energy savings and emission reductions
  • Food and Drug Administration (FDA) audit support and responses
  • Corrective Action/ Preventative Action (CAPA) identification and implementation
  • Emergency Response and Community Right-to-know Act (EPCRA) reporting
  • Leak detection and repair (LDAR) programs
  • Hazardous waste storage tank certification (RCRA Subpart J)

Representative Projects

  • Development of compliance programs for new air emissions regulations specific to pharmaceutical operations
  • Renegotiation of air permit to increase operational flexibility for API manufacturing facility
  • Wastewater and stormwater permitting for start-up API manufacturing facility
  • Energy efficiency improvements for multi-building biopharma manufacturing campus via HVAC system recommissioning
  • Audit of air emission compliance, including corrective actions, for manufacturing facility
  • FDA audit response for oral solid dosage facility