Environmental Health and Safety Services
BioPharmaceutical Specialization

Harris & Lee Environmental Sciences, LLC has inside experience within the Biotechnology and Pharmaceutical business sector. We understand the EH&S risks and issues of biotechnology (large molecule) and pharmaceutical (small molecule) research, development, and manufacturing that only inside experience provides:

• We provide unique skill sets in understanding the EH&S risks and issues of both the biotechnology and pharmaceutical sides of drug development and manufacture.
• We understand the business, technologies, fast-paced work environment and EH&S issues of the industry.
• We can support a flexible approach that meets the business need.
• Our track-record of success is based on excellent relationship-building skills with all levels of the business, from manufacturing operators to R&D Scientists, to executives.
• We provide high-level training to help internal EH&S teams navigate changes in business strategy, and mergers and acquisitions.

We have the ability to support biotech/pharmaceutical companies with established EH&S organizations through special program support and/or projects, such as the following:

• IH monitoring (including active pharmaceutical ingredients and surrogate monitoring),
• Job hazard analysis, and
• Identified compliance or strategic initiatives.

Our experience includes Potent Compound/Hazardous Drug Safety Program Development and Implementation.

• Unique experience in building a program from scratch -- getting senior management approval, building consensus, and getting an effective program in place in a collaborative manner.
• Successful program elements include:
  o  Administrative requirements,
  o  Contract manufacturing interaction requirements,
  o  Medical surveillance appropriate to job task and risk level,
  o  Training,
  o  Handling requirements appropriate to the job,
  o  Detailed design criteria for new build-outs and remodels, and
  o  IH monitoring program requirements (including provisions for surrogate monitoring).

We are currently supporting both start-up and midsize biotech and pharmaceutical companies to successfully manage EH&S compliance as they grow the business.

Biotechnology and pharmaceutical EH&S projects are handled by Patricia Beach, MS, CIH, REA, a Senior EH&S professional with ten years hands-on experience in Biopharmaceutical and Pharmaceutical development/manufacturing. For further details please call us at (415) 287-0056 or contact Ms Beach via email.
 

INFO BOX Harris & Lee awarded "2009 Best Environmental Firm"

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CONTACT INFO Harris & Lee Environmental Sciences, LLC Based in Northern California with offices in Santa Rosa and San Francisco Santa Rosa: (707) 571-8961 San Francisco: (415) 287-0056 Email P.O. Box 8369 Santa Rosa, CA 95407