Running a pharmaceutical business in Singapore means dealing with strict regulations, complex quality requirements, and constant pressure to stay audit-ready. GQS Singapore takes that burden off your team — with practical, hands-on pharma consulting that gets you compliant and keeps you that way.
What Is Pharma Consulting?
Pharma consulting means getting expert support to navigate the regulatory, quality, and compliance requirements that every pharmaceutical business in Singapore must meet. This includes GMP compliance, product registration, quality system development, regulatory submissions, staff training, and audit preparation — all of which require specialist knowledge that most in-house teams simply do not have the bandwidth to manage alone.
Who We Help
- Pharmaceutical manufacturers seeking or maintaining HSA manufacturer’s licences
- API (Active Pharmaceutical Ingredient) manufacturers required to meet GMP standards
- Drug importers and distributors managing product registration and GDP compliance
- Clinical research organisations (CROs) running trials in Singapore
- Medical device companies needing ISO 13485 certification alongside pharma quality requirements
- Health supplement and nutraceutical manufacturers requiring FSSC 22000 or GMP compliance
- Food and pharma manufacturers needing PCQI certification for US FDA FSMA compliance
Our Pharma Consulting Services
GQS Singapore provides that expertise — across the full pharmaceutical product lifecycle, from development and manufacturing through to distribution and post-market compliance.
GMP Compliance and Implementation
We help you build, implement, and maintain a full Good Manufacturing Practice system aligned with HSA requirements and the PIC/S GMP Guide — covering documentation, facility qualification, process validation, change control, and CAPA. Visit the HSA GMP and GDP Standards page for official requirements.
Regulatory Affairs and HSA Submissions
We guide your team through product registration, variation submissions, and licence applications with Singapore’s Health Sciences Authority (HSA). We ensure your dossiers are complete, accurate, and submission-ready — reducing rejection risks and delays.
Quality Management System Development
We build your complete QMS from scratch or strengthen what you already have — SOPs, batch records, validation protocols, deviation management, and audit trails. This pairs naturally with our ISO 9001:2026 quality management consultancy.
Good Laboratory Practice (GLP) Certification
For pharmaceutical companies conducting non-clinical safety studies, GLP compliance is mandatory. GQS Singapore’s GLP certification consultancy ensures your laboratory systems, data integrity, and study protocols meet international GLP standards.
GDP — Good Distribution Practice
Pharmaceutical distributors and importers must comply with HSA’s GDP requirements to maintain their dealer licences. We audit your warehousing, cold chain management, and distribution processes and bring them fully into compliance.
HSA Inspection Preparation and CAPA Support
We prepare your team for HSA GMP and GDP inspections — what inspectors look for, how to present documentation, and how to respond professionally. If your inspection results in observations, we help you draft and close your CAPA response within HSA’s required timeframe.
Staff Training
GMP awareness, GLP principles, GDP requirements, documentation best practices, deviation reporting — we train every level of your workforce in plain, practical terms.
Frequently Asked Questions
1. Does GQS Singapore handle both GMP and regulatory submissions?
Yes. We support both quality system implementation and HSA regulatory submissions — saving you the cost and coordination of managing separate consultants.
2. Do you work with small pharma manufacturers in Singapore?
Absolutely. We work with organisations of all sizes — from small specialty manufacturers to large multi-site pharmaceutical groups — and tailor our engagement to your specific scale and budget.
3. Can GQS Singapore help with CAPA after a failed HSA inspection?
Yes. We specialise in post-inspection CAPA development and implementation, helping you close HSA observations professionally and within required deadlines.