What We Do
GPDS provides a wide range of consulting services with seasoned Consultants across various quality system elements in the pharmaceutical, biotech, and medical device industries. Our projects are reviewed and defined with clear scope and milestones with clients to ensure successful completion and satisfaction. Areas of services include but not limited to, the following:
GxP Compliance Consulting
Auditing: Each experienced GXP Auditor in our organization conducts an average of forty audits each year in both medical device and pharmaceutical industries worldwide. Regulation and Standards covered include:
- FDA Regulations (GxP)
- ISO 9001
- ISO13485
- Canadian Regulations (CMDR)
- MDD
- AIMDD
- IVDD
Validation: Our services include protocol development, review, execution, and approval.
- Computer Software
- Computer Hardware
- Manufacturing Process
- Test Method
- Autoclave
- Refrigerator
- Freezer
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- Lab Equipment
- Cold Chain
- Cleanroom
- Aseptic Process
- In-Situ Efficacy Evaluation of Disinfectants
- Incubator
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Regulatory Submissions: Regulatory submissions include the following:
- NDA
- INDA
- ANDA
- PMA
- 510K
- Registration and Listing
Consent Decree Management: We provide cost-effective solutions in handling statements of work under a consent decree.
SOP Development: We develop Quality Management Systems (SOPs) to support new companies, new processes and improvement of existing processes
Training: We provide GXP training with certificates of training recognized by third-party industry auditors. Our training programs include:
- Lead Auditor Training
- CAPA Implementations
- OOS Investigations and Root-Cause Analysis
- Design Control
- Good Laboratory Practices
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- Good Clinical Practices
- Good Documentation Practices
- Aseptic processing
- Validation
- ISO Registration Process
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Clinical Trial Management: Services include protocol generation, site identification and qualification, site monitoring, site closeouts, and clinical study team training.
