Environmental Health and Safety - Biotechnology and Pharmaceutical  Consulting Services

We understand the EHS risks and issues of biotechnology (large molecule) and pharmaceutical (small molecule) manufacture that only inside experience provides.

  • We know biotechnology and pharmaceutical manufacture from the inside: the technologies, fast-pace, needs and EHS issues.
  • We support a flexible approach that meets your business needs.
  • Our track-record of success, both compliance and strategic, includes excellent relationship building skills.
  • We provide unique skill sets in environmental health and saftey risks and issues of both the biotechnology (large molecule) and pharmaceutical (small molecule) sides of drug development and manufacture.
  • We provide high-level training to help internal EHS teams navigate changes in business strategy, and mergers & acquisitions

Harris & Lee Environmental Sciences specializes in support of start-up biotechnology companies:

  • Turn-key service for all EHS programs and deliver what is needed for effective compliance
  • Straight-forward processes and procedures
  • Focused training designed for various work environments (office, lab, manufacturing)

We support larger companies with established EHS organizations through special program support and projects:

  • IH monitoring (including potent pharmaceutical API, surrogate monitoring),
  • job hazard analysis
  • compliance
  • strategic initiatives.

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

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

We help start-up and midsize biotech and pharmaceutical companies successfully manage environmental health and safety compliance as the business grows.

Biotechnology and pharmaceutical environmental health & safety projects are handled by Patricia Beach, MS, CIH, REA, a Senior EH&S professional with seven years hands-on experience in Biopharmaceutical and Pharmaceutical development and manufacturing. For further details please call us at (707) 571-8961 or contact Ms. Beach via email.