After having spent 17 years in the pharmaceutical and biotechnology industries, Steve Roberts founded the company in 2002. It was his belief that companies could experience an enhanced benefit from his broad experience and knowledge in a number of inter-related disciplines, used in the development and launch of clinical and commercial supplies. These covered a variety of dosage forms and products produced in a GMP setting. In addition, clients would further benefit from his diverse education in Science, Engineering, Quality, and Business Management.
Prior to consulting, Steve held both staff and senior level management positions in a number of key functional areas. These included:
- Formulations & Process Development
- Manufacturing & Packaging Process Engineering
- Manufacturing, Packaging & Warehousing Operations Management
- Facilities & Equipment Design and Qualification
These jobs were with a number of industry leading organizations such as:
- Wyeth Laboratories
- ICI Pharmaceuticals (now AstraZeneca)
- Atlantic Pharmaceutical Services (now Shire Laboratories)
- Colorcon / Micron Technologies
- ProClinical (now Sharp Clinical Services)
- Genaera Corporation
Since the company's inception, it has consulted to a vast number of industry-related organizations. Included are Pharmaceutical, Biotechnology, Medical Device, API, Dietary Supplement, Raw Material, Component, and Analytical Testing companies. Roberts Pharmaceutical Consulting has been retained as both a Technical and Quality resource by a number of professional corporations such as Legal firms and other consulting practices.
A major strength of the company has been its Quality Assurance support services. Perhaps there is no more important aspect to the successful execution of a project than its conformance to industry regulations and standards. As such, we offer a full-complement of QA services. These include Auditing (200+ cGMP audits conducted to date), Investigations, CAPA Remediation, SOP Development, GMP Training and Quality Systems Development and Implementation.
To ensure that we always maintained a primary focus on satisfying our customers' needs, the company was re-structured in 2006. Darcie Roberts joined the company as its Owner and EVP, responsible for all business management functions. In addition, the company joined a network of industry consultants, each of which is an expert in their particular discipline. As needed, Roberts Pharmaceutical Consulting manages their work on your behalf to ensure that your requirements are always met.
We welcome and appreciate the opportunity to review our services relative to your particular project's needs. Please call 610-361-9541 or email sroberts@pharmleader.com or droberts@pharmleader.com to do so. Thank you.
Steven C. Roberts, AAS, BA, MBA
President
Darcie L. Roberts, BS (Honors)
Owner, Executive Vice President
