Service Offerings
 | Training, Teambuilding & Development Services |
 | cGMP, GLP (FDA, EPA, OECD), EMEA, Australian GMPs, QSR, | |
| Canadian GMPs, LAR, NATA | ||
| ISO 9001 & ISO 17025 | |
| Dietary Supplements GMP (21 CFR Part 111) |
| Technology Solutions for R&D |
| Process Upgrade (PAT) | |
| Cleaning Validation, Devices, Aseptic Validation | |
| Development of Formulations/Solid Dosage Forms | |
| ISO 9001 & ISO 17025 |
| Dietary Supplements GMP (21 CFR Part 111) |
| Auditing & Assessment Services |
| GLP Audit (FDA, EPA, OECD) | |
| Auditing Regulatory Submission of IND, NDA & ANDA, 510(k), IDE | |
| REACH (EU) Compliance | |
| ISO 9001 & ISO 17025 | |
| Dietary Supplements GMP (21 CFR Part 111) |
| Validation Services & Document Preparation |
| Analytical Problem Solving | |
| Development of MVP/CAPA | |
| Microbiology Validation | |
| GLP (FDA Part 58 Quality Systems) | |
| ISO 9001 & ISO 17025 |
| Dietary Supplements GMP (21 CFR Part 111) |
| REACH: Lab Data Modeling/Risk Assessment Scenarios | |
VALQUAL INTL.
Auditing and Assessment Services
Our auditing and assessment services can uncover potential issues before they
result in noncompliance findings within your organization. VQI conducts audits in
several areas focusing on various aspects of compliance:
result in noncompliance findings within your organization. VQI conducts audits in
several areas focusing on various aspects of compliance:
| Independent Assessment Activities | |
| GLP Facility Audit/GAP Assessment | |
| GLP Study Audit/SOP Audit (21 CFR Part 58) | |
| GMP Assessment (GLP/GMP ISO/QSR) | |
| Quality Systems/CAPA Systems | |
| Document Preparation/Master Validation Plan & Technology Solutions | |
| GMPs for Dietary Supplements | |
Validation Services
We provide validation services in the areas of pharmaceutical and biotech validation.
We have the ultimate resources available to resolve validation issues at all levels.
These resources can assist in developing a comprehensive approach for targeting
compliance in validation:
We have the ultimate resources available to resolve validation issues at all levels.
These resources can assist in developing a comprehensive approach for targeting
compliance in validation:
| Analytical and Microbiology Validation, Software Validation | |
| Instrument Validation (IQ, OQ, PQ) Computer Systems, HPLC, LC-MS, TOC, GC | |
| Water Quality Validation, Cleaning Validation | |
| Process Validation & CpK Measurements | |
| Various Regulatory Issues, Stability (ICH) | |
| Adapting On-Line Measurements in Process Engineering/Production (PAT) | |
| For more information contact: Dr. Shib Mookherjea ValQual International 16 Fairchild Place Whippany, NJ 07981 Phone: 201-615-6346 Fax: 407-498-2027 shib@valqualintl.com Administrative Manager Wendi Petrone Fax: 864-963-7899 wpetrone@valqualintl.com |
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