Ready for an FDA inspection? Let DDC help you prepare with pre-inspection audits,
coaching, and help man your war room during the inspection. our services contact us Are you prepared for a data integrity audit? DDC computer system and QC laboratory experts can provide training,
prepare risk assessments, and recommend migration pathways
for legacy equipment to be Part 11 compliant. our services contact us Did you just receive a list of 483 observations? We can assist you with all FDA communications. our services contact us Did you receive a warning letter? Our team can help plan and implement remediation activities. our services contact us

About Double Dragon

Double Dragon Consulting provides a diverse range of consulting services to life sciences companies worldwide.

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Our Experience

We have a long history of solving problems effectively and efficiently, at significant cost savings to our clients.

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Our Associates

We customize the DDC project team to ensure that your project requirements are met.

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Trusted by pharmaceutical companies worldwide.

Our services include:

Engineering

Engineering services offered by DDC or through our alliance partners includes design (conceptual design, basis of design, detailed design), and EPCM (Engineering, Procurement, and Construction Management in Asia (China, Taiwan, Singapore, Vietnam, Japan, Indonesia). Learn more

Project Management

Project Management services offered by DDC include development and execution of compliance remediation project plans to address Health Authority (FDA, EMA, MHRA, CFDA, etc) and customer observations. Example activities include planning and management of retrospective and prospective batch record review, QC release testing assessments, QMS gap assessments / remediation, investigations (deviations, OOS, customer complaints), annual product reviews (APR). In some cases, set up and operation of a Project Management Office (PMO) is recommended. Learn more

Data Integrity

Data Integrity services include enterprise-wide data integrity assessments and strategies for minimizing risk, detailed review of audit trails (including QC Laboratory and Manufacturing Operations). Recommendations for remediation activities include instrument and software purchase recommendations, computer system validation (CSV).  DDC’s data integrity training includes techniques used by the US FDA. Learn more

Quality and Compliance

Quality / Compliance services include Quality Management System (QMS) gap assessments and remediation, including SOP development. We can help you prepare for a Health Authority audit, set up and operate a “war room” during an audit, and help with Health Authority correspondence. Remediation activities include retrospective and prospective batch record review (including manufacturing and QC test records), training, investigations (deviation, OOS, customer complaint), annual product reviews. Learn more

Training

Often the result of reductions in staffing, training organizations frequently lack the personnel and oversight required to ensure training effectiveness. Areas of focus include adequacy of staffing, training effectiveness, training materials (including course content, curricula), training methods, record keeping and reporting, and trending of deviations. Learn more

Sourcing Management

We help clients identify quality suppliers, qualify suppliers, evaluate and monitor supplier performance. Learn more

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