PharmOut’s Pharmaceutical Consultants have helped pharmaceutical manufacturers in the Australia, New Zealand and most of Asia Pacific region comply with TGA, MedSafe, PIC/S, EU and US FDA GMP regulatory requirements.
Many in our team have previously held roles within regulatory bodies such as the Australian Therapeutic Goods Administration (TGA) and we can offer expertise on a fee for service basis or a fixed price basis to provide niche expertise to your next project from start to end.
US FDA CFR Part 11 compliance means complying with the regulatory requirements for Electronic Records and Electronic Signatures (ERES) as outlined in the US Code of Federal Regulations (CFR) Part 11, or those documented in EU or PIC/S Annex 11.
Receiving a notice of deficiencies after an audit by a regulator is never pleasant. For some companies it will mean major remediation efforts are required, for others it may mean having to address a few small issues. PharmOut can help prepare your GMP Audit Response.
We offer a range of auditing options for a number of industries which can cover GMP Compliance, Regulatory Inspections and Post-Audit Remediation Programs all to TGA, FDA and EMEA standards.
PharmOut employs a number of ex-Australian Therapeutic Goods Administration (TGA) inspectors as consultants and we can help you with obtaining pharmaceutical regulatory approval from the TGA.
Pharmaceutical GMP compliance can be tricky – which regulations, which interpretation, where to start? We can help you develop a GMP compliance roadmap to guide you on your way.
Our GMP technical writing team is carefully recruited to not only provide you with an experienced technical writer but a writer who also brings GMP consulting strength to your project.
We can offer registration strategies and assistance to companies who wish to supply products to the Australian market but are unfamiliar with the regulatory requirements.