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:
- Administrative requirements,
- Contract manufacturing interaction requirements,
- Medical surveillance appropriate to job task and risk level,
- Handling requirements appropriate to the job,
- Detailed design criteria for new build-outs and remodels, and
- 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.