Enimera RegsPlus is a consultancy company formed around the principles of integrity, innovation, and commercial success.
Our clients are pharma, biotech and wellness organisations seeking exceptional service in the development and commercialisation of their medicines and medical devices in Australia (TGA), New Zealand (Medafe), the (FDA) and Europe.
We have experience from concept to commercialisation to drive or complement your US or European regulatory strategy.
We are experts with TGA (Australia) and Medsafe (New Zealand) regulatory matters, and can provide strategic advice and operational support to complement your commercial outcomes.
Whether you need an extra pair of hands, a feasibility assessment prior to embarking on a costly activity, or an options analysis to address a challenging scenario, the Enimera RegsPlus team can help.
Regulation of therapeutics can be complex, and nuances in interpretation of the Regulator requirements can lead to project delays and increased costs.
EnimeraRegsPlus offers an approach which tests basic regulatory assumptions in providing tailored options and guidance for your project.
In addition to Regulatory support, Enimera RegsPlus offers Pharmacovigilance (QP and local literatue search) and Quality (QA) services compliant to TGA and Medsafe requirements.
EnimeraRegsPlus offers training and mentoring for aspiring or new managers.
EnimeraRegsPlus also offers reviews and effectiveness checks for teams seeking to operate at their fullest potential. These checks are tailored for the disciplines often collectively termed Scientific Affairs – Regulatory Affairs, Clinical Research, Quality, Medical Affairs, Medical Information Pharmacovigilance and Health Economics.
EnimeraRegsPlus assists researchers to understand the downstream product development and regulatory considerations of commercialisation, allowing for better a articulation of the value proposition.
To tertiary students (undergraduate and postgraduate) and individuals in the medical research field seeking a career with pharmaceuticals, biotechnology or medical technology organisations, EnimeraRegsPlus offers tailored mentoring programs.
We are experts in medicinal cannabis, whether you seek to navigate the TGA Special Access Scheme of Authorised Prescriber pathways, undertake clinical trials, or develop a medicine for registration.
chemistry/manufacture/controls and technology transfer to GMP manufacture, non-clinical development, clinical development
