GMP compliance consultants
PharmOut Singapore is an private GMP consultancy, specialising in the HSA GMP requirements, and is part of the network of PharmOut companies across the Asia Pacific.
In Singapore, PharmOut offers:
- GMP consulting to Singapore Health Sciences Authority ( HSA ) requirements
- Australian TGA product registration services
- Validation services
- GMP training.
We help pharmaceutical, medical device and complementary/Chinese medicine manufacturers achieve compliance to HSA GMP, MHRA GMP, EU GMP, PIC/S GMP and/or WHO GMP requirements. Details of our products and services are listed on our global website.
We believe in taking a very practical approach to GMP compliance - implementing simple systems that will both help you achieve GMP compliance and run your manufacturing operations efficiently.
Our GMP consultants have encountered most of the issues that occur in HSA regulated GMP facilities like Pharmaceutical, Medical Device and Biotechnology manufacturers.
We work with both multinationals and small to medium companies. Typically, we help Quality Assurance, Validation Managers and Engineering Managers within those companies increase profits and export to international markets by becoming GMP compliant.
Our Team
Our team includes:
- GMP Consultants
- Validation engineers
- TGA Regulatory Affairs Consultants - to support product exports to Australia
- GMP Training consultants
- Technical Writers, pharmaceutical engineers and specialists.
PharmOut’s team includes international GMP experts and consultants who have held leadership roles within regulatory bodies such as PIC/S.
More information about our GMP compliance services can be found on our global website.
Our industries
PharmOut supports industries who are subject to the various GMP codes regulated by the Singapore Health Sciences Authority, PIC/S, MHRA, GHTF, FDA and the EU, including manufacturers of:
- Pharmaceuticals
- Medical devices (including IVDs)
- Complementary and Chinese medicines
We use a risk based approach to target the areas that have the most impact on product quality – rather than simplistically treating the whole process equally.
More information about the industries we support is available on our global website.
The projects we take on
- GLP/GMP/GCP Quality Management Systems, compliant with HSA GMP codes
- GMP Audit readiness assessments and remediation to FDA CFR 210/211, CFR 820
- Providing assistance with obtaining approval from international Regulatory GMP bodies such as the FDA, EMA, MHRA Part 11 and Annex 11 compliance to FDA requirements
- Drug and device registration with the Australian TGA.
Read case studies of our work on our global website.
Contact us
Contact details for our Singapore office and international offices.