Medsafe GMP compliance and validation consultants
PharmOut is a network of GMP consulting companies, operating across the Asia Pacific. In New Zealand, we offer Medsafe GMP consulting and GMP training to help pharmaceutical, medical device and complementary medicine manufacturers achieve Medsafe compliance. Full details of our products and services are listed on our global website.
PharmOut prides itself on the practical application of regulations ensuring compliance in the manufacturing world. Our professional staff have experienced most of the problems that can occur in the Pharmaceutical, Medical Device and Biotechnology manufacturers.
As Pharmaceutical professionals we have extensive knowledge of current compliance regulations and keep abreast of any changes to these to ensure that our customers are always compliant.
We work with multinationals companies and small companies just starting out. Typically we deal with Quality Assurance, Validation Managers and Engineering Managers within pharmaceutical companies looking to enhance business profits and export to international markets by ensuring that all of their staff understand and work towards becoming compliant.
Our Team
Our team includes:
- Medsafe GMP Consultants
- Validation Consultants
- TGA Regulatory Affairs Consultants
- Professional Trainers
- Technical Writers and other life science specialists.
We can deliver highly experienced consultants or contractors at short notice.
PharmOut’s team includes international GMP experts and consultants who previously held leadership roles within regulatory bodies.
More information about our GMP compliance services can be found on our global website.
Our industries
PharmOut consults to those industries subject to the various GMP codes regulated by Medsafe, TGA, PIC/S, GHTF, FDA and the EU, including:
- Pharmaceutical manufacturers
- Medical device manufacturers
- Manufacturers of veterinary and pesticide products.
We use a risk based approach to focus on the areas that will have the most impact on product quality – rather than simply treating the whole process equally. We also deliver practical compliance solutions that deliver business benefits as well as compliance.
More information about the industries we support is available on our global website.
The projects we take on
- GLP/GMP Quality Management Systems, compliant with Medsafe GMP codes
- Audit readiness assessments and audit remediation to FDA CFR 210/211, CFR 820
- Implementing Quality Management Systems for Pharmaceutical or ISO 13485 for Medical Device standards
- Assistance with obtaining approval from international Regulatory GMP bodies such as the FDA, EMA, MHRA or the TGA Part 11 and Annex 11 compliance to FDA and TGA requirements
- Preparation of dossiers for drug and device registration with the TGA.
Read case studies of our work on our global website.
Contact us
Contact details for our New Zealand office and international offices.