Formulytica partners with biotech and pharmaceutical companies to solve complex formulation and CMC challenges and accelerate the path to clinical- and commercial-ready products.

We are an Australian contract development and manufacturing organisation (CDMO) specialising in complex formulation, analytical development, and integrated CMC programs across pharmaceutical, biotech, veterinary, and adjacent healthcare products. Beyond executing defined scopes of work, we work closely with clients to guide critical technical decisions, reduce development risk, and enable efficient progression from early-stage development through to clinical supply and beyond.

With over a decade of experience, and a team averaging around 20 years in the pharmaceutical industry, Formulytica brings deep expertise across topical, injectable, oral, and ophthalmic drug delivery systems. We support a wide range of modalities, including small molecules, peptides, and biologics. Our core strength lies in developing robust, stable formulations and analytical strategies that address key challenges such as solubility, stability, bioavailability, manufacturability, and patient acceptability.

We have extensive experience across dosage forms including topical creams, gels, and aerosol foams; oral solutions; ophthalmic products including eye drops and injections; as well as injectable solutions, liposomes, and nanoparticle-based drug delivery systems. We are particularly experienced in translating technically challenging assets into scalable, regulator-ready products.

Our model bridges the gap between development and GMP manufacture. Through established partnerships with TGA-licensed and FDA-audited manufacturers covering sterile and non-sterile dosage forms, we support scale-up and supply of investigational products for Phase I and II clinical trials in Australia and internationally. This enables a seamless transition from laboratory development into GMP manufacture within a compliant, globally relevant framework.

Formulytica works with clients across Australia, the US, Europe, and Asia, supporting development programs targeting international regulatory pathways and product launches.

Why work with us

Formulytica is designed for organisations that need more than execution. We act as a hands-on development partner, combining scientific depth with practical CMC insight to help clients make better decisions, avoid technical dead-ends, and progress faster towards clinical and commercial milestones.

Partner, not just provider

We work closely with clients to shape development strategy, not just deliver work packages. This includes identifying risks early, prioritising the right experiments, and aligning development decisions with regulatory, manufacturing, and commercial realities.

Focused on complex and challenging programs

We specialise in technically difficult products, including poorly soluble compounds, unstable actives, biologics, and advanced delivery systems. Our experience across liposomes, nanoparticles, topical systems, ophthalmics, and injectables allows us to solve problems that can delay or derail development programs.

Bridging development and GMP manufacture

Our integrated model connects early formulation and analytical development with GMP manufacturing through established partner organisations. This reduces technology transfer risk, shortens timelines, and supports efficient progression into clinical trials.

Designed for speed and decision-making

Clients engage Formulytica not only for execution, but for clarity. We help teams move forward with confidence by providing data-driven recommendations, practical trade-offs, and development strategies that are aligned with real-world manufacturing and regulatory expectations.

Flexible partnering models

In addition to fee-for-service engagements, we participate in co-development programs, in-licensing opportunities, and structured commercial arrangements including royalty or profit-sharing models where aligned. We also maintain an internal innovation pipeline and are open to partnerships to advance novel assets into the clinic.

Globally relevant, locally efficient

Based in Australia, we operate within a highly regarded regulatory environment with strong links to TGA and FDA-aligned manufacturing and clinical ecosystems. This enables clients to access high-quality development and clinical pathways suitable for global programs, often with advantages in speed and efficiency.