Formulytica specialises in:
Topical and injectable formulation development. New product development and the analytical science of semi-solid formulations for topical application utilised in dermatology, pharmaceutical, cosmetic, veterinary and personal care products, such as skincare and haircare. Our injectable parenteral expertise covers solution and lipid based formulations, in biologics, as well as small organic molecules.
- Solutions for New Chemical entities, generics and cosmetic
- Development of new products for the Australian, US, EU and Asian markets to meet regulatory and market requirements for human and veterinary products.
- Managing the complete product development and life cycle process through dedicated project management.
- Development of patentable technologies and processes as part of product and analytical development.
- Understanding competitor product and patents.
- Gap analysis of your existing R&D and implementing modified processes to suit your company and staffing creating efficiencies for your business.
How we work
Formulytica provides:
- Clear project plans and costs.
- Control over all aspects of CMC documentation and defence for submission.
- Value through patent documentation, critical experiment inclusion and response.
- Rigorous product development through Design Space for formulation and manufacturing, with a focus on QbD and Design of Experiments adoption of lean processes.
- Full process development with technical transfer to manufacturer.
- Trouble shooting including in development, scientific based marketing claims and support for products,
Leadership Team
Our Management and Directors
Dr Michael Andrews Luke is a PhD-qualified scientist and R&D leader with over 20 years of experience developing and launching new products in the biotechnology, pharmaceuticals, and cosmetics industries. Michael’s previous employers include Aesop, Arana Therapeutics, GlaxoSmithKline, and Imunexus.
Michael brings a skillset that combines technical expertise, innovation, operational management and R&D leadership. In addition to managing commercial clients, he has overseen the growth of an innovation portfolio spanning nucleic acid (RNA) and peptide delivery systems, dermatological and ophthalmic therapeutics, and GMP-ready injectables, and has overseen many partnerships with industry and academia, leading to patent applications, multiple millions of dollars received in funding from grants and private investment, and successful initiation of phase I and II clinical trials.
Rose is a PhD-qualified Chemist with over 25 years of experience as an analytical scientist in the pharmaceutical industry. Rose is an expert in analytical method development, validation and stability testing for pharmaceuticals including prescripion and over-the-counter medicines, as well as consumer products, spanning dosage forms including Topical, Injectable and Oral.
Rose has more than 20 years experience leading and managing an analytical team to support product development. She has been a CMC leader for a number of drug products that have been successfully launched in international markets, and is an expert in analytical techniques with sound theoretical and regulatory knowledge, as well as practical skills.
Billie Roughan, PhD, brings over 18 years experience across the biotechnology, pharmaceutical, and cosmetics industries. Her career spans diabetes research, transdermal product development, and the creation of innovative topical and injectable pharmaceutical, veterinary, and personal care products.
As Chief Operating Officer (COO) at Formulytica, Billie combines her scientific expertise with strategic leadership to drive operational excellence and business growth. She oversees day-to-day operations, optimises processes, and ensures alignment between innovation and execution across the organisation.
Passionate about delivering high-quality, functional products that make a difference, Billie continues to lead a dynamic formulation team while shaping Formulytica’s operational strategy to support sustainable growth and client success.
Richard is PhD and MBA qualified with more than 28 years of experience in the pharmaceutical and veterinary industry where he developed numerous vaccines, injectables and topicals. Whilst employed previously with Stiefel Research Laboratories and Glaxo Smith Kline, Richard led project teams developing topical products, which resulted in a number of successful aerosol and foam product launches in the United States. He has also developed a single dose veterinary vaccine technology which has been successfully marketed for the past 20 years.
Richard served as Formulytica’s CEO and Managing Director through the first 10 years of the company’s operations, and remains involved as a Non-Executive Director and Advisor.
