LENEXA, Kan., Dec. 16 /PRNewswire/ -- EaglePicher Pharmaceutical Services (EPPS) has launched a new service designed to help pharmaceutical manufacturers manage regulatory affairs. With this service, EaglePicher will assist clients in preparing quality-related documents such as Drug Master Files (DMF), Chemistry, Manufacturing and Control (CMC) sections, scientific protocols, training modules, technical development reports, Standard Operating Procedures (SOP) and FDA meeting packages. In addition, EaglePicher will advise clients on various aspects of Active Pharmaceutical Ingredient (API) development such as setting up specifications for critical materials, regulatory requirements and planning the CMC regulatory strategy.
“Small and virtual pharmaceutical facilities with limited personnel resources appreciate the convenience of having this new service at the manufacturing site,” said Steve Westfall, president of EaglePicher Pharmaceutical Services. “EPPS is pleased to provide its clients with the full range of expertise needed for their API development under one umbrella. EPPS clients receiving the service have seen benefits such as reduced costs, faster development, higher efficiency and increased confidentiality.
To ensure the highest level of service, EPPS recently hired Dr. Kalpana Nimkar as Regulatory Affairs Manager. Dr. Nimkar has a Ph.D. in Synthetic Organic Chemistry and a solid background in the CMC area of drug development. She has six years of experience in Regulatory Affairs and cGMP Compliance pertinent to API manufacturing activities.
Dr. Nimkar’s experience includes the preparation and maintenance of over 40 Drug Master Files in the US, Europe and Canada, IND-CMC sections, DMF Amendments and Annual Reports and Certificate of Suitability Dossiers. Dr. Nimkar also has assisted numerous organizations with product and establishment registrations.
“Dr. Nimkar’s expertise is a valuable addition to the services currently offered by EPPS,” commented Westfall. “EaglePicher’s Quality Assurance program has benefited tremendously from her extensive experience in the cGMP compliance area.”
Recognized for its expertise in developing and manufacturing cytotoxic and high-potency drugs, EPPS continues to grow. While its radiochemistry group continues to provide radiolabeled drugs (carbon-14 or tritium) for animal drug metabolism studies, EPPS has expanded its services into supplying radiolabeled cGMP materials for clinical trials. In addition, EPPS’s development chemists continue to provide unmatched technical assistance for its clients’ drug development programs.
EaglePicher Pharmaceutical Services, LLC, a division of EaglePicher Technologies, LLC, has been a valued resource for the development and manufacture of APIs and the leading expert on cytotoxic/high-potency pharmaceuticals for more than 30 years. With broad experience, expert staff, and state-of-the-art equipment, labs and isolated suites, EaglePicher Pharmaceutical Services can take active ingredients from pre-clinical development through commercial production. The business specializes in the custom cGMP synthesis of pre-clinical, investigational and commercial APIs, radiolabeled compounds and cytotoxic/high-potency pharmaceuticals at FDA- inspected, USA-based facilities.
EaglePicher Technologies, LLC, a wholly owned subsidiary of EaglePicher Incorporated, has facilities in Colorado, Missouri, Oklahoma, Kansas and Canada. The operating group develops and markets advanced high-reliability power systems and associated electronics for government, space and commercial applications. It also processes Boron isotopes, anticancer pharmaceutical ingredients and ultra clean scientific containers. Areas of global focus include telecommunications, medical, nuclear power plants, space, defense, environmental, semiconductors and pharmaceutical/biotech. Additional information is available on the Internet at http://www.eaglepicher.com/ .
EaglePicher Incorporated, founded in 1843 and headquartered in Phoenix, Arizona, is a diversified manufacturer and marketer of innovative, advanced technology and industrial products and services for space, defense, environmental, automotive, medical, filtration, pharmaceutical, nuclear power, semiconductor and commercial applications worldwide. The company has 4,000 employees and operates more than 30 plants in the United States, Canada, Mexico, the U.K. and Germany. Additional information on the company is available on the Internet at http://www.eaglepicher.com/ .
This release contains statements which, to the extent that they are not recitations of historical fact, constitute “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934. These include any statements about future business operations, financial performance or market conditions. Such forward-looking information involves risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties are discussed in Eagle-Picher Holding’s filings with the U.S. Securities and Exchange Commission.
EaglePicher(TM) is a trademark of EaglePicher Inc.
EaglePicher Pharmaceutical Services, LLC
CONTACT: Steve Westfall or Scott Parker of EaglePicher PharmaceuticalServices, LLC, +1-913-541-0525
Web site: http://www.eaglepicher.com/