Our Expertise

Technical Knowledge is the Difference

cGMP Compliance

Do you need help assuring that your existing or new facilities comply with the latest cGMP?

cGMP Compliance Services

In a global economy, to remain competitive and compliant, manufacturers are faced with a broad range of regulations from organizations such as the FDA, EMA, WHO, SFDA and PIC/S. It requires special expertise to navigate through the changing regulatory environments across several types of regulated facilities, from aseptic and medical devices to biotech facilities. Our Subject Matter Experts are industry leaders and have such extensive experience working with these requirements that they are often called upon to train industry regulators.

How can Genesis help you?

From start to finish, whether auditing an existing facility or building new, we understand your needs. Our subject matter experts don't just know regulation, they know engineering and how to design, build, commission, and validate compliant facilities. This practical experience gives us an advantage in reviewing existing and new facility operations. Our solutions assure compliance with constructability and cost effectiveness. We push the envelope to assure compliance with quality and efficiency.

cGMP Compliance Experience

cGMP Compliance Expertise
  • Environmental Control / HVAC
  • Compressed Air
  • High Purity Water
  • Commissioning and Qualification
  • Building Automation / GAMP
  • Material, Personnel, Product, and Waste Flows
cGMP Compliance Services
  • cGMP Compliant Facility and System Designs
  • Facility Compliance Audits
  • Technical Opinions and Peer Reviews
  • Facility Compliance Planning
  • Clean Build
  • Qualification
  • Validation
cGMP Compliance Facilities
  • Aseptic
  • Oral Solid Dose
  • Liquids, Creams, and Ointments
  • Medical Devices
  • Excipients
  • Nutraceutical
  • API
  • Biologics
  • Tissue Processing

Subject Matter Expert

Norman A. Goldschmidt
Senior Principal
V.P. Engineering

cGMP Compliance Team

Bernard C. Friel, P.E.
Phillip M. Patterson, P.E.
Joshua L. Blair, CBCP

Project Profiles

Representative Clients

  • Amgen
  • BMS
  • Catalent
  • GlaxoSmithKline
  • Johnson & Johnson
  • Lannett
  • Merck
  • NIH
  • Novartis
  • Roche
  • Sidra
  • Spark
  • Teva
  • WL Gore
  • Wuxi

Representative Projects

  • Aseptic Fill/Finish
  • Cell Therapy
  • Clinical Manufacturing
  • Gene therapy
  • Human Tissue Processing
  • Medical Device Manufacturing
  • Oral Solid Dose Manufacturing
  • Therapeutic Proteins