Services

Documentation

Creation and enhancement of critical QMS documentation such as Site Master Files, Quality Manuals, SOPs, and other essential working documents to ensure regulatory alignment.

Developing tailored Site Master Files

Drafting and updating Quality Manuals

Creating and revising SOPs

Designing clear Work Instructions - Regular document reviews and updates

QMS Implementation

Comprehensive support for the planning, integration, and establishment of a Quality Management System tailored to meet ISO 9001 and ISO 13485 standards.

Assessment of current processes and gap analysis

Development of a customized QMS implementation plan

Integration of ISO 9001 and ISO 13485 requirements

Creation and alignment of QMS documentation

Continuous monitoring and improvement of the QMS

Training Programs

Training for staff on implementing and sustaining a QMS, covering all core aspects of quality management to build confidence and competence within the team.

Comprehensive training on QMS principles and requirements

Instruction on effective document control and management

Training on conducting internal audits and reporting findings

Workshops on handling non-conformances and corrective actions

Hands-on training tailored to team-specific needs

License Applications & Amendments

Guidance through the process of regulatory license applications and amendments, ensuring accuracy and adherence to regulatory standards.

Assistance with preparing and submitting regulatory license applications

Guidance on amendments to existing licenses

Support with addressing queries or deficiencies raised by regulators

Regulatory & Client Audit Support

Assistance in preparing for regulatory audits and client inspections, from initial preparation through response planning and corrective action support.

Conducting pre-audit gap analyses and self - inspections

Providing guidance on audit preparation and readiness

Creating and updating required documentation

Ensuring timely implementation of corrective and preventive actions (CAPAs)