Thaeta works with clients in Australia, Asia, Europe and the USA in the dynamic field of Regulatory Affairs /Compliance, Quality Assurance and R&D. The core areas of expertise, include Complementary Medicines, Listed Medicines, Medical Devices, IVD’S, Cosmetics, Industrial Chemicals, Over the Counter Medicines (OTC), Agricultural and Veterinary items.
First established in 2012, We provide Regulatory Compliance, Validation, and Engineering Consulting Services to pharmaceutical and Medical Devices companies. We create solutions for our clients on a project basis and find the root of structural issues. We care about people, first and foremost. We thoroughly vet and choose the most experienced consultants to get the best result for our valued clients.
Our comprehensive solution will give you the support you need until you have met Regulatory Compliance requirements prior to commercial distribution worldwide.
Thaeta can assist with regulatory submissions within Australia, New Zealand, Europe and USA, along with product formulations, product development, Quality Management Systems and obtaining Third Party Clinical Reports/Trials. We can assist in simplifying the complex world of regulations and product development in pharmaceuticals.
Thaeta’s Consultants assist manufacturers in their regulatory processes. Clarify the numerous requirements in the European Directives and Regulations, Therapeutic Goods Administration(TGA), The New Zealand Medicines and Medical Devices Safety Authority (Medsafe), Food & Drug Administration(FDA), for In Vitro Diagnostics and Medical Devices, propose practical solutions to meet them or compose your technical documentation and design dossiers. Whether you only need training in the Directives and Regulations or you want to outsource your regulatory affairs activities completely, Thaeta can provide a suitable solution. While doing this, we take your ambitions globally into account.
Internally every project is a team project. The challenges of the regulatory environment are that no one person can know everything. We apply a team approach. We rely on each other to create pathways through complex regulatory requirements.
Externally, we work closely with the clients, our third-party industry experts, and Government Regulators. This collaborative approach is the key to our success. We deal with complex issues and innovative new products prior to release into the industry and guide the communication with the government bodies to achieve the best possible outcomes.