At SIL Pharma
We help pharmaceutical, biotech, and clinical research organisations build and maintain robust, compliant, and audit-ready quality systems. With expertise in GMP, GCP, and ISO requirements, we provide end-to-end support in QA compliance, risk and gap assessments, supplier audits, and technical writing — ensuring your operations are aligned, efficient, and audit-ready.
- Suppliers Quality Audits
- QA Compliance
- Support for Clinical Trials
- Technical writing
Suppliers Quality Audits
We provide professional Quality Management System (QMS) auditing services to ensure compliance, efficiency, and continual improvement. With over 25 years of experience in the pharmaceutical and clinical research sectors, we conduct audits aligned with GMP regulatory requirements, GCP guidelines and ISO standards and to identify gaps, assess risks, and strengthen quality systems.
Our auditors hold Certified Quality Auditor (CQA) certification and apply a standardised approach to ensure efficient, effective, and value-driven assessments. Our audits go beyond compliance as we focus on improving processes, supporting regulatory readiness, and fostering a culture of quality that drives better processes and products.
QA Compliance
We provide expert Quality Assurance (QA) compliance services to help organisations maintain robust, audit-ready quality management systems that meet regulatory requirements and industry standards. We ensure alignment with GMP, GCP and ISO requirements through practical and risk-based approaches.
Our approach is to work collaboratively with our clients to strengthen their quality systems, streamline processes, investigate and close non-conformances/CAPAs, prepare risk assessment and foster a culture of continuous improvement and regulatory excellence.
Support for Clinical Trials
We provide expert support in the development of high-quality documentation for Human Research Ethics Committee (HREC) submissions and clinical trial management. We assist sponsors, researchers, and clinical teams by preparing clear, compliant, and well-structured submission packages, including study protocols, Participant Information and Consent Forms (PICF), Investigator Brochures (IB), and associated regulatory and quality documents.
In addition, we support clinical trial planning, site start-up, vendor oversight, study coordination, and compliance activities to ensure projects run efficiently and meet regulatory expectations.
Technical Writing
We provide professional technical writing services tailored to the quality management systems in the pharmaceutical, clinical research, and medical device sectors.
Our focus is on clarity, accuracy, and practicality — ensuring every document communicates complex information effectively while meeting regulatory and organisational requirements.
