Dane Renshaw Email & Phone Number

Talofa, Nsw, Au

Brisbane, Australia

Working with brands to create quality products that are scientifically backed and fully compliant. 𝗥𝗘𝗚𝗨𝗟𝗔𝗧𝗢𝗥𝗬 𝗔𝗙𝗙𝗔𝗜𝗥𝗦• Preparation of evidence packages• Regulatory submissions• Updating indications to permissible indications• Listing products on the ARTG• Creator of formulations that have ingredients that work and claims that resonate (listed medicines, complementary medicines, foods & cosmetics)• Generating copy for labels and marketing• Responding to Section 31 notifications• Responding to Section 30 notifications• Development of stability protocols• Government liaison• Product specifications review for accuracy and compliance• Ingredient analysis for efficacy and compliance• Label and marketing copy compliance assessment𝗧𝗥𝗔𝗜𝗡𝗜𝗡𝗚 & 𝗘𝗗𝗨𝗖𝗔𝗧𝗜𝗢𝗡• Masterclass Facilitator - product development and regulatory affairs topics.

Brisbane, Queensland, Australia

End to end service for health and wellness brands. We can project manage from concept to launch or any part thereof that will allow your business focus on growth. 𝗣𝗥𝗢𝗗𝗨𝗖𝗧 𝗗𝗘𝗩𝗘𝗟𝗢𝗣𝗠𝗘𝗡𝗧 • Proof of concept and positioning.• Formulation and ingredient selection. • Stability Protocols and testing.• Manufacturing and sourcing. • Clinical Research, claims substantiation, regulatory compliance.𝗦𝗢𝗨𝗥𝗖𝗜𝗡𝗚• Global and local reach for ingredient sourcing.• Packaging𝗠𝗔𝗡𝗨𝗙𝗔𝗖𝗧𝗨𝗥𝗜𝗡𝗚• Established local contract manufacturers network• We will manage your purchase order to ensure that it is delivered in full and on time.

Sydney, New South Wales, Australia

Bespoke strategy, product development, sustainable supply chain, regulatory affairs and technical expertise. Partnering with wellness brands to make product development effortless. • Discover - drill into problem identification, definition and prioritisation. Define clear objective. • Design - review strategy, competitive landscape, ideal format, ingredient and packaging selection.• Develop - formulation development, regulatory submission, marketing.• Deliver - ready product for launch at ideal time. Founded in partnership with Gabriel Perera.

Brisbane, Australia

• Ensure compliance across range to Therapeutic Goods Administration (TGA) Regulations, Therapeutic Goods Administration Act, Evidence guidelines for listed complementary medicines and Therapeutic Goods Advertising Code.• Good Manufacturing Practice (GMP) Compliance• Standard Operating Procedures (SOP)• Regulatory Affairs• Product Regulatory Submissions• Corrective and Preventative Actions (CAPA)• Evidence backed claim substantiations• New Product Development• Product Innovation• Trend analysis for ingredients and finished products. • Design Control• Global Sourcing• Batch upscaleAccomplishments• Increasing revenue from new product development by 561% (2017 to 2018)• Successfully launching product ranges into multiple international marketsincluding China, India, Philippines, Dubai and Singapore.• Re-establishing Bio Concepts as an innovative and respected brand.• Improving systems and processes to streamline the journey from initial conceptthrough to market evaluation and administration.

Ballina

Advanced Wellness Regulatory Solutions is a private regulatory consulting firm specialising in the complementary medicines industry. Solutions focused, providing valuable support and advice to clients in all aspects of regulatory affairs.• Thorough understanding of the Therapeutic Goods Administration (TGA) Regulations, Therapeutic Goods Administration Act, Evidence guidelines for listed complementary medicines and Therapeutic Goods Advertising Code. • Providing a high level of research skills for evidence package compilation and therapeutic indication substantiation. • Providing research and development skills to assist clients with product formulations and suitable ingredient choices to support desired therapeutic indications.• Processing complex data and critiquing clinical trials for suitability as per the TGA evidence guidelines. • Preparation of product specifications and stability protocols. • Perform comprehensive and documented literature reviews and systematic reviews of ingredients for therapeutic use. • Thorough understanding of the Food Standards Australia New Zealand Food Standards Code. • Research and development of food products including Formulated Supplementary Sports Foods, Formulated Meal Replacements and general purpose foods with appropriate food related health claims. • Developing procedures and processes to improve efficiencies and reduce risk.• Website and marketing material reviews for compliance with appropriate regulatory bodies. • Training of staff and clients in various aspects pertaining to regulatory affairs and evidence package preparation. • Thorough understanding of cosmetic guidelines and regulatory requirements pertaining to cosmetics and secondary sunscreens.

Lismore

I worked as a tutor assisting the delivery of the following chemistry units: 1. Chemistry for Health Sciences;2. Exercise Biochemistry and Drugs in Sport. I provided assistance to the lecturer in educating the students and explaining complex information and laboratory techniques during the laboratory components of the units. I was also involved in the assessment process.• Delivered laboratory class objectives and demonstrated required techniques to achieve chemical investigation outcomes. • Explained methods and techniques to perform separation of mixtures and identification of substances by physical properties. • Isolated natural products and active compounds using laboratory techniques and procedures.• Demonstrated distillation methods for separation and purification of organic liquids. • Communicated scientific information in a language that is easy to understand and process. • Described literature review methods and processes for preparation of scientific reports and compiling and presenting scientific data. • Educated students on how to collect, interpret and present biochemical experimentation data in a laboratory report and critically discuss the findings. • Marked the major end of unit laboratory assignments and provided feedback to students to assist them with future study and unit objective outcomes.

Southern Cross University, Lismore

Southern Cross Plant Science is an Australian leader in phytochemistry, pharmacology and testing physical and chemical properties of therapeutic goods. In my role I performed an extensive literature review of Australian native plants traditionally used for wound healing and subsequently investigated the in vitro wound healing potential of over 200 selected species. My ability to understand and interpret complex information and communicate effectively between different groups involved in the project was vital in compiling extensive quantities of data and organising information to assist with future research goals.• Provided high level research skills for literature reviews and laboratory investigation techniques.• Interpreted complex data and compiled results for publication purposes.• Performed laboratory based cytotoxicity, anti-inflammatory and antioxidant assays. • Trained staff and students in laboratory techniques and investigation protocols.• Compiled Material Safety Data Sheets and occupational health and safety documents. • Prepared and extracted plant materials for laboratory investigations. • Maintained cell cultures for in vitro laboratory investigations.

Southern Cross University, Lismore

• Performed herbal authentication of natural products. • Assisted staff in laboratory methods and techniques.• Prepared herbal material for extraction purposes. • Assisted with the organisation of material for a large natural product research project.