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Services Offered
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Services are based on 6-sigma (6-σ) and Total Quality Management (TQM) principles / methodology. |
Validations (Retrospective / Concurrent / Prospective)
- Process
- Equipment
- Facility
- Cleaning
- Test Method (TMV)
- Computerized systems (Part 11)
- Client / Server / Network
- PLC
- PCS / SCADA
- Automated System
- Software
- ERP / MRP
- CAPA systems
- Laboratory
- Calibration Management System
- V&V
- Documentation Management Systems
Quality Assurance / Engineering
- Design of Experiment Studies (DOE)
- Change Control
- Document Control
- Process Capabilities (Cpk)
- Batch Verifications
- Stability / Kinetics
- PMA / 510K submission help
- INDA / NDA submission help
- Develop Test Methods / SOP's
- Corrective Action / Preventive Action (CAPA)
- Pre-approval Inspection (PAI) Preparation
- Resolve 483's / write-ups, and CD's
- RMA's
Training
- GMP
- QSR
- GLP
- Part 11
- Validations
- Audits
Audits
- Documentation
- Vendor / Supplier
- Validation
- Facilities
- cGLP / cGMP / QSR
- Process
- Warehouse
- Part 11 - Gap analysis
- DEA Auditing
Safety
- Cal-OSHA
- Fed-OSHA
- Proposition 65
- EPA
Development & Product Transfer
- Characterize processes / formulations
- Develop methods, equipment and systems
- Simplify processes (downstream / upstream)
- Product Transfer R&D to Manufacturing
- Product / Process Xfer - Facility
- Reduce Failure rate
- Business Strategy Evaluation
- Factory Acceptance Testing / Site Acceptance Testing (FAT / SAT)
Environmental Monitoring
- PM count
- RODAC™ sampling
- Surface Swabbing
- RCS Sampling
- Water PM / Bioburden
- Product Bioburden
Reference Accounts
Work Detail Performed for previous clients
Skills
Accomplishments
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It's not only about compliance but also savings of time and money!
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Increased inter and intra-departmental performance.
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Reduced wasted capital, time and effort.
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Increased Customer Satisfaction.
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Increased Profit.
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Why choose me over the others?
What sets me apart from others:
- I work mostly independently and have very little overhead. Only when necessary, I utilize experts from my network who hold supreme expertise in their field (e.g. Certified Industrial Hygienist, ex-FDA agents, etc.)
- I make sure that my client is fully satisfied even if that means working even harder.
- I am incorporated so I can work 1099 or W9 (corp-to-corp).
- I research subject matter thoroughly and am up-to-date with regulatory and technical positions.
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I have repeat clients since the beginning of my consulting career.
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I am hardworking and assertive, delivering the highest quality work with respect to thoroughness and deadlines.
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I am innovative and creative in my approach and have pharma / medical device experience since 1995.
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I do not price gouge. My rates are much lower and tailored towards low to mid level budgets.
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Providing Quality & Validation Services for the Pharmaceutical, Medical Devices, Biotech and other industries within North America, Europe, Asia, Australia, and other areas of the world. More Details. |
Providing validation and compliance services that meet your
schedule and budget.
More Details. |
Stay current with regulations and industry demand. We create affordable deliverables and provide validation and QE services that stand up to the FDA inspections.
More Details. |
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