Quality Compliance Partners, Inc. can:

ü       Assist you in developing/enhancing a Quality System that is Phase Appropriate yet can grow with you.

ü       Develop, enhance or harmonize Policies, Procedures and SOPs

ü       Assess and provide a gap analysis and recommendations for compliance with US/EU/Other Standards

ü       Assist in developing or enhancing of Quality Assurance subsystems

ü       Provide qualified professionals to manage or assist with daily or periodic quality assurance activities, special projects (e.g. EDMS) or help with backlogs

QCP, Inc. quality professionals have hands-on experience which includes, but is not limited to:

·         Quality System Design and Improvement

·         Quality Manuals

·         Vendor Management & Qualification

·         Auditing

·         Document Management Systems (paper, electronic)

·         Management Responsibilities

·         Change Control

·         Deviations Management and Support

·         Corrective and Preventive Action (CAPA)

·         Nonconformance Management

·         Annual Product Reviews (APR)

·         Master Batch Record Reviews (MBR)

·         Post Marketing Surveillance

·         Product Complaints Handling (including writing

·         MDRs and MDVs)

·         Investigation Support

·         Compliance Assessments

·         Efficiency Assessments

·         Quality Reviews of Validation

·         Quality System Design and Improvement

·         Nonconformance Management

·         Deviations Management and Support

·         Investigation Support (Batch Failure, OOS, etc.)

·         Inspection Readiness

·         QA Guidance for Contract Manufacturers and Laboratories

·         QA Data Review

·         QA Support for Tech Transfer