Clinical/Commercial
Quality Systems (Dev., CAPA, CC)
Batch Record Review
Auditing/Gap Analysis
GMP/GCP/GVP Support
Regulatory Affairs
Quality Compliance
Inspection Preparation
Inspection Support
Commitment Management
Regulatory Documents
Chemistry
Experience in the lab from toxicology studies to commercial products and with everything from method development and validation, instrument qualification and validation to stability testing .
What keeps you up at night?
Let Us Do The Work For You
Our consultants are skilled at stepping into complex and challenging situations to make immediate and significant contributions to alleviate your most pressing issues.
Putting SOPs In Place...
Our consultants are experienced technical writers that can efficiently write policies and procedures for your organization.
Oversight/Support...
Whether it is providing direct assurance of GXP records (e.g. batch records, deviations, investigations, CAPAs, etc.) or supporting projects such as validation or continuous improvement, our knowledgeable consultants are ready.
Professional Development Services
What would you, your colleagues, or employees like to learn more about or refresh your training on?
Basic GMPs
Annual cGMP
483 Review
Quality Systems
Deviations
Root Caues Analysis
CAPAs
Quality Management Review
And more....
WRITE A MESSAGE
If you have any questions, please do not hesitate to send us a message.