Companies work with Double Dragon because of our accomplishments and network of consultants.
Double Dragon provides a wide range of services, including engineering/design and EPCM, quality/compliance assessments and remediation, validation (computer systems, process, cleaning), supply chain support, project management, and GMP (including data integrity) training. We have significant experience working with pharmaceutical companies in all dosage forms, and with construction, commissioning, maintenance and operation of aseptic processing facilities.
A word about our consultants – rather than employees who may not have the skills / experience needed for your project, we draw from a global network of associates. In this way, we are able to customize project staffing, to guarantee the right experience and maturity for your engagement. The associates we will use for your project are seasoned professionals, have hands-on work experience, and in the past have worked with more costly consulting companies.
Our consulting model benefits you in the following ways:
- Staffing customized for your project, based on knowledge, experience
- Project staffing levels not restricted by employees tied up with other projects
- Lower cost
Learn more about our capabilities at a glance:
Engineering Services:
Design Class A/B Cleanrooms to meet US, EU, and China requirements
Evaluate facility layouts & manufacturing processes
Evaluate HVAC system, Utilities, Automation system
Establish personnel and materials flow
Provide guidance on Equipment Qualification and Commissioning
Provide guidance on Media Fills
Establish Maintenance Program
Project Management Services:
Develop and execute Project Plan with milestones, timelines and resources
Develop, track, and report appropriate KPIs
Set up and man a Project Management Office (PMO) for complex projects
PM support including bilingual (Chinese / English)
Quality and Validation Support Capabilities:
Provide guidance on procedures, processes, and documentation to meet US and EU requirements
Establish Validation Master Plan (VMP)
Establish or evaluate validation protocols (process, equipment, cleaning, analytical methods, etc.)
Evaluate change control, deviation, and validation reports
Training Services
- Data Integrity audit training, to include how to audit a QC laboratory and Manufacturing operations applying FDA audit techniques
- GMP (general, specific – US, EU, China)
- Aseptic Operation including Gowning Qualification
- Quality Risk Management (QMS), to include Deviations Management, Root Cause Analysis, CAPAs, OOS / Lab Investigations, Customer Complaint investigations
- Internal Audits (including Data Integrity in the lab and shop floor)
- Technical Writing
Sourcing Management
We help clients identify quality suppliers, qualify suppliers, evaluate and monitor supplier performance.
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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.
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Quality and Compliance
Quality / Compliance services include QMS gap assessments, SOP development, Health Authority audit preparation, war room set up and operation during an audit, correspondence with Health Authorities, remediation activities such as retrospective and prospective product release reviews, training, investigations (deviation, OOS, customer complaint), annual product reviews.
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Project Management
Project Management services offered by DDC include compliance remediation, such as retrospective and prospective batch record review, QC release testing reviews, QMS development, investigations (deviations, OOS, customer complaints), annual product reviews (APR), set up and operation of a Project Management Office.
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Data Integrity
Data Integrity services include audits, investigations, remediation, and training in techniques used by the US FDA.
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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).
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