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Regardless of company size, DHG Associates, Inc. offers assistance to pharmaceutical industry management. Combining a wide ranging industry background with frequent US and offshore regulatory authority interactions, DHG Associates can supplement a firm’s capabilities, serve as their US Agent, while assisting them to reach the most cost effective solutions for rapidly moving new products to market and for successfully maintaining current products in the market.

• Following receipt of a Warning Letter by a US producer of active pharmaceutical ingredients involving loss of government contracts and refusal of new filing approvals, we were requested to negotiate a Compliance Schedule with the local District office. Upgraded facilities, systems, and validation practices; restructured DMF filings; retrained personnel and returned plant to full compliance in agreement with the negotiated schedule.
• Conducted economic evaluations and due diligence reviews of Canadian oral and parenteral dosage manufacturers for possible acquisitions by an offshore company planning to enter the North American market .
• Prepared all conceptual design and validation program criteria for barrier design vial filling and lyophilization capacity and upgrading expansions of a Puerto Rico parenterals plant while maintaining the plant in continuing operation.
• Called in when a US producer faced major source code and hardware validation issues with a Customer Service System networked to control drug product inventories and shipments from both manufacturing and distribution center sites we installed change control over all procedures, designed and executed hardware qualification and software validation programs; and, reviewed final reports with local District for acceptance
• Obtained initial FDA inspection approval for an NCE by  a  Pacific Rim producer after their earlier receipt of a Warning Letter. Installed and trained local staff in plant and laboratory quality systems; selectively modified the plant facilities; supervised the facility qualification and process validation programs. All work was reported in the local language with only summary reports translated into English.
• Developed the design criteria and regulatory filing strategy for a US sited $25MM grass roots multiproduct oral dosage cephalosporin facility. Installed quality and validation systems; structured the preapproval inspection readiness program; presented qualification and validation summaries at the PAI obtaining initial visit FDA approval.
• Directed the facility qualification and process validation program for a fully computerized drug substance plant .
• Obtained full FDA approval for decontamination of former beta-lactam plants, enabling facilities to beneficially used for manufacture of new  chemical entities and   dosage  forms.
• Called in by top management of a multi-national offshore conglomerate operation a domestic drug substance production plant .  The plant experienced a difficult FDA inspection and had failed after several months to develop an appropriate response.  Immediate management concern was to avoid a Warning Letter. Within a week, our team assessed the full scope of the situation, organized a response program and developed an implementation timetable for presentation to the District Office.  We accompanied firm management to the meeting.  The Warning Letter was averted.  The corrective action plan is in progress.