Discover our services

At Safeguard QA, we offer expert consulting to enhance your Pharma Quality department and ensure compliance with global regulatory standards. From gap analysis to certification, our services cover every aspect of pharmaceutical quality assurance. Partner with us to support your growth and compliance goals.

Quality Management System

Develop, implement, and maintain Pharma QMS, including self-inspection and gap assessments to evaluate regulatory compliance. Assess and manage risks, support with standard operating procedures (SOP) development, and manage GMP/GDP records during storage and transportation.

Personnel & Training

Provide training on global & local Pharma regulations, and specialized programs for internal staff and Responsible Persons (RP). Deliver in-house or remote training, including GMP, GDP, and GUI 0069.

Audits & Inspections

Conduct internal audits, assist with external audit preparation, and ensure audit readiness with mock inspections.

Facilities & Equipment

Support qualification and validation of facilities, processes, temperature monitoring, equipment maintenance, including sanitation/pest control programs.

Documentation & Compliance

Implement Good Documentation Practices following ALCOA+ principles, with Change Management and Record Retention Programs.

Management & Leadership

Develop and maintain Management Review Programs focused on continuous improvement.

Deviations, Incidents & CAPA

Manage programs, such as: Deviations, Incidents, CAPA, Returns, Recalls, and Complaints with technical support.

Specialized GDP Services

Tailored support for EU and Albanian wholesalers

Quality Agreements & Licenses

Assist with Quality Agreements and licensing preparation for compliance.

Operations Support

Maintain GMP/GDP Quality Systems, including Quality Risk Management, Computer System Validation, and data integrity monitoring

Specialized GDP Compliance Services:

  • GDP Gap Assessment & Action Plan

  • QMS and SOP development

  • RP advisory support

  • Internal audits & mock inspections

  • GMP and GDP training

  • Supplier & transport provider qualification

  • Temperature mapping & validation

  • Data integrity & record-keeping compliance

Contact us

Interested in the services above? Fill out info and we will be in touch shortly.

How We Deliver

Our expert consultants guide you from consultation and gap analysis to implementation and certification, aligning your systems with business goals and standards.