SOURCE: CLX Investment Company, Inc.

December 03, 2007 08:45 ET

CLX Investment Company Announces Safis Solutions, LLC to Provide Services Related to Regulatory Approvals for Subsidiary Medical Technologies

MURRIETA, CA--(Marketwire - December 3, 2007) - CLX Investment Company, Inc. (OTCBB: CLXN), which owns 51% of Zonda, Incorporated, a developer and manufacturer of unique diagnostic tests for the medical and non-medical markets, today announced that Safis Solutions, LLC has been engaged to provide ongoing consulting services in the areas of regulatory approvals and quality systems for Zonda and additional potential future medical diagnostic technologies acquired by CLX.

Safis Solutions (, an Indianapolis-based regulatory compliance consulting company serving pharmaceutical, medical device and biotech companies worldwide, has been retained as a sub-contractor of American Health Partners, LLC (AHP), which has been engaged by CLX to assist with the launch of medical diagnostic testing products in its subsidiary operations. Safis Solutions has over 20 full-time staff, as well as partnerships with more than 60 other experts in their respective fields.

The immediate focus of Safis Solutions' work on behalf of CLX will be Zonda's rapid point of care test for Chlamydia. Safis Solutions will guide the development of a quality system that is compliant with the IVD Directive 98/79/EC and ISO 13485. This involves review and updating of all Standard Operating Procedures (SOPs) as they relate to manufacturing, procurement, management, quality assurance and contracting. In addition, Safis Solutions will function as Zonda's quality manager until such time as Zonda brings that function in house.

Safis Solutions will also design, implement and manage clinical trials that meet the requirements of U.S. and international regulatory bodies. Upon completion of the clinical trials, Safis Solutions will prepare and submit documents for FDA clearance, waived status under the Clinical Laboratory Improvement Act of 1988 (CLIA) and CE marking for sale of products in the countries of the European Union.

Gretchen Bowker, M.S., RAC, Director of Regulatory Affairs Services and Compliance Services for Safis Solutions, will oversee the Zonda project. Ms. Bowker has over 20 years of experience in life sciences product development in both start up and large pharmaceutical and device companies. She has successfully negotiated approvals/activations of U.S. and European market approvals. She also has extensive experience in building and overseeing a life science company's Quality System and programs. As a trained protein chemist, Bowker specializes in global Chemistry Manufacturing and Control (CMC) regulatory requirements for biotechnology products, such as proteins, peptides and cellular based therapies.

Vera Leonard, president and chief executive officer of CLX Investment Company, commented, "We are pleased to have Safis Solutions on board to provide ongoing consulting services for Zonda's rapid point of care test for Chlamydia, as well as any additional medical diagnostic testing products that are associated with CLX in the future.

"Safis Solutions is expected to provide support to Zonda's management team in the formulation of plans and decisions as they relate to quality and regulatory issues, and we believe that working with professionals with this depth of experience and expertise greatly augments Zonda's efforts to bring these unique and important products to the worldwide healthcare market," Ms. Leonard added.

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About CLX Investment Company

CLX Investment Company ( holds a 51% equity interest in Zonda, Inc. Information regarding Zonda can be found on its official website, CLX has also invested, and holds a common stock position, in ActionView International, Inc. (, a publicly traded global manufacturer and marketer of "smart" scrolling advertising billboards.

All statements included in this release, including statements regarding potential future plans and objectives of CLX Investments are forward-looking statements. Such statements are necessarily subject to risks and uncertainties, some of which are significant in scope and nature beyond CLX Investments' control. There can be no assurance that such statements will prove accurate. Actual results and future events could differ materially from those anticipated in such statements depending on many factors. Historical results are not necessarily indicative of future performance.

Contact Information

  • Contact:
    Gemini Financial Communications
    A. Beyer
    Email Contact

    Safis Solutions, LLC
    Diana Caldwell
    Email Contact