Pharmaceutical and Medical Device companies are routinely inspected by regulators and notified bodies as per their legal requirements.
SeerPharma is routinely engaged by companies to help prepare for these inspections (i.e. mock audits) and/or respond to findings made by these authorities.
Our team of experts can conduct mock inspections to identify and address gaps and suggest improvements. We make you aware of what inspectors are looking for during an actual inspection. Consultants deliver structured reports in the same way as an inspection report from a regulatory agency.
Effectively responding to Regulators requires a thorough, detailed and closed-loop approach. Our Consultants can support you through the language and actions required to ensure the best outcome.
Our team has extensive experience helping companies with inspections from bodies such as:
- Therapeutic Goods Administration (TGA) – Australia
- Food and Drug Administration (FDA) – USA
- Australian Pesticides and Veterinary Medicines Authority (APVMA) – Australia
- Health Science Authority (HSA) – Singapore
- National Pharmaceutical Regulatory Agency (NPRA) – Malaysia
- MedSafe – New Zealand
- EU QP Audits
- EU Authorities
- BSI (Notified Body)
- TUV Sud (Notified Body)
Contact us to learn more about our GxP audit support, or click the below button to learn about our range of GxP auditing services.
