Our experience extends across the full range of therapeutic goods from prescription to complementary medicines, and to all types of medical devices (including diagnostics and software), or any combinations thereof. Our experience also extends beyond therapeutic goods to include cosmetics, disinfectants, and food products.
Additionally, with our understanding of various thinking perspectives, we function effectively in circumstances requiring situational flexibility. This enables us to successfully deliver a broad range of services and outcomes that add value and regularly exceed client expectations.
Jeanette Lodge
BSc, Grad DipBiotech, MMedSc (Drug Development)
Director – Principal Consultant,
Founder of Mister Wolf Consulting
About Jeanette
Jeanette is a highly experienced professional with approximately 30 years experience in the healthcare industry. Over this time, Jeanette has held roles in production, regulatory affairs and quality assurance in both a corporate and consulting environment.
Jeanette established her own company, Mister Wolf Consulting Pty Ltd in early 2018, having worked in two separate regulatory, quality and clinical consulting firms for a combined total of 13 years. Prior to that, Jeanette held various positions in a global healthcare company.
Jeanette provides valued and insightful advice and strategic support for projects involving medicines (prescription, biological, OTC and listed), medical devices, or both. She has submitted and managed a large number of medical device and medicine applications in both Australia and New Zealand and has been involved in all aspects of regulatory maintenance and product life-cycle management. She has developed effective working relationships with various TGA and Medsafe evaluators and other staff within these and other agencies and has also been involved in pre-submission consultations with the TGA on a variety of topics.
Jeanette also has experience with cosmetic products and the importation of industrial chemicals. Additionally, as a qualified lead auditor, Jeanette has experience in the development, implementation and assessment of quality management systems, notably in accordance with ISO13485.
Jeanette has a Masters in Medical Science and a Graduate Diploma in Biotechnology.
Anita Keith
BAppSc (Nutrition)
Senior Consultant
About Anita
Anita is a regulatory consultant with approximately 20 years of pharmaceutical industry experience in both the private and public sector, including the TGA. Anita has worked as a Regulatory Associate and Project Manager and more recently as a Regulatory Consultant. Anita has worked mostly with prescription medicines, including vaccines but more recently has assisted clients with over-the-counter medicines, complimentary medicines, and devices.
Of note, during her 5 years of consulting, Anita has worked with clinical and non-clinical experts to systematically review and compile Literature Based Submissions.
During her 20 years in the pharmaceutical industry Anita has also spent a short period of time working with General practitioners to identify targeted health outcomes and the best scientifically supported treatment practices to achieve these outcomes. This work has provided Anita with an understanding of real-life use of medicines and the practical use of clinical data generated for regulatory submissions.
When Anita is not working for clients she is helping her husband on their rural NSW farm and taking her teenage children to music lessons and sport.
Greg Pearce
BPharm, Dip Hosp Pharm, PhD
Senior Consultant
About Greg
Greg is a registered pharmacist with post graduate qualifications in clinical pharmacology. He has over 30 years’ experience working in operational and managerial roles in the Australian and New Zealand pharmaceutical industry in regulatory affairs, drug safety, medical affairs and health economics, in both the innovative and generic sectors of the industry.
Over the last 7 years he has worked as a regulatory consultant, providing support to sponsors in the prescription, over the counter and complementary medicines sectors. During this time, his main focus has been in reviewing and developing non-clinical and clinical documentation to support literature-based submissions (LBS), scientific justifications, product reviews and risk management plans (RMP). Over this period, he has been involved in over 12 LBS applications and 6 RMP.
Prior to working in the pharmaceutical industry, he worked as a clinical pharmacist in NSW tertiary referral hospitals and as an academic at the university of Sydney. He has a strong interest in quality use of medicines and balancing medicine innovation with timely and equitable access.