Sam McWilliams & Associates, Inc. – Chemical & Process Safety Engineering Consultants
Pharmaceutical Industry Solutions
Pharmaceutical Industry Solutions
Trusted Partner to the Pharmaceutical Industry
Ensuring Safety, Compliance, and
Efficiency in Pharmaceutical Manufacturing
The pharmaceutical industry operates under some of the most stringent safety and regulatory requirements in the world. At Sam McWilliams & Associates, we provide expert consulting services designed to help pharmaceutical manufacturers maintain compliance, ensure product integrity, and safeguard both workers and communities. With decades of experience across regulated industries, we understand the unique challenges faced by pharmaceutical operations and deliver solutions that drive both safety and operational excellence.
Our Expertise in the Pharmaceutical Industry
We combine deep knowledge of process engineering, process safety management, and hazard analysis with an understanding of regulatory frameworks such as FDA, OSHA, and EPA requirements. Our goal is to help pharmaceutical companies streamline operations while upholding the highest standards of safety and compliance.
Key Services We Provide
Process Hazard Analysis (PHA)
Facilitating HAZOP, What-If, and LOPA studies tailored to pharmaceutical processes, ensuring risks are identified and mitigated.
Process Safety Management (PSM) Compliance
Helping facilities align with OSHA standards for handling highly hazardous chemicals and supporting compliance with industry-specific regulations.
Engineering and Technical Support
Providing scale-up design, debottlenecking, equipment evaluation, and process optimization to support safe and efficient production.
Audits and Training
Conducting compliance audits, gap assessments, and tailored workforce training to keep your teams knowledgeable and compliant.
Why Choose Us for Pharmaceutical Solutions?
- Regulatory Expertise: Knowledgeable in FDA, OSHA, and industry-specific compliance requirements.
- Tailored Approach: Customized services that reflect the unique needs of pharmaceutical operations.
- Unbiased Guidance: Independent of equipment and technology providers for truly objective solutions.
- Comprehensive Support: Covering everything from early-stage design to full-scale commercial production.
Areas We Support in Pharmaceuticals
- Active Pharmaceutical Ingredient (API) manufacturing
- Finished product formulation and packaging
- Biopharmaceutical and biotech processes
- Sterile and aseptic processing facilities
- Laboratory and pilot plant operations
Partner With Us
When it comes to pharmaceuticals, there is no room for error. Partnering with Sam McWilliams & Associates gives your team access to experienced consultants who understand the critical balance between safety, compliance, and efficiency.
Contact us today to learn how we can support your pharmaceutical operations.
