Reliant FDA Experts Cost Effective FDA Compliance Consultants

Reliant FDA Experts qualified new construction modular clean rooms for compliance with ISO classification. In order to provide a cost-effective qualification, the custom IOQ/PQ qualification protocols were generated offsite and the protocols were executed by a team of Reliant resources to expedite execution time. Following the execution, the qualification reports were generated offsite and a complete qualification package was provided to the client.

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Reliant FDA Experts assisted with the multiple qualifications required as part of a major facility renovation. The qualifications required included several utility and equipment qualifications. In order to provide cost-effective and compliant qualifications, the custom IOQ/PQ qualification protocols and reports were generated primarily offsite following the client’s validation program procedures and templates. The qualifications were performed according to the client’s approved programs and culture with Reliant recommendations.

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Reliant FDA Experts performed a comprehensive cGMP assessment for a manufacturer looking to convert to a fully compliant OTC pharmaceutical manufacturer. In order to provide a cost-effective assessment that provided a wide, detailed look at their facility, it was decided that a five (5) day assessment would be performed including quality system, facility and adequate staffing assessments. Prior to the assessment, specific assessment criteria were developed based on regulations and common industry practices. The results of the assessment were provided to the client via an assessment report which detailed the specific observations and provided full recommendations and proposed costs for remediation of the observations.

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Reliant FDA Experts generated and presented a customized full day training of compliance topics pertaining to cGMPs/QSRs that applied to the client’s specific logistics facility. In order to provide a cost-effective and effective training, the training materials were customized for the client’s operations and presented onsite in a full day training presentation. Following the training, Reliant’s resource spent an additional half day onsite for an open consulting question and answer period to ensure all questions were fully addressed.

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Reliant FDA Experts recently generated a Drug Master File (DMF) amendment and annual report for a drug component manufacturer. This project is the latest installment in a project which was started years ago with client convenience in mind. The original DMF, all amendment and annual report submissions have all been generated by our consulting firm as part of an open agreement with the client. Each year, the client is contacted with reminders that the annual report is coming due. The complete package is put together and mailed to the client with detailed instructions on how to perform the submission.

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Reliant FDA Experts performed a targeted equipment/utilities qualification assessment for a contract manufacturer of cell-based products. In order to provide a cost-effective assessment that provided a wide, detailed look at their qualification, it was decided that an assessment would be performed on a client chosen selection of qualifications. Prior to the assessment, specific assessment criteria were developed based on regulations and common industry practices. The results of the assessment were provided to the client via an assessment report which detailed the specific observations and provided recommendations for both corrective and preventive actions.

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