About Us

Following studies in industrial chemistry, Nick enjoyed a variety of laboratory roles over a seven year period including stability monitoring, manufacturing process validation and analytical method development and validation.  During this time he led teams to complete analytical studies and the resulting reports for submission to global agencies.  In 2005 Nick moved to the UK and began his career in European regulatory affairs where he coordinated marketing authorisation applications to various European authorities.  Upon his return to Australia, Nick led a regulatory affairs team responsible for writing, publishing and submitting CTD dossiers for generic products to Europe, USA, SE Asia and Australia.

In 2009 Nick co-founded Pharma To Market with Johanna where they work with clients locally and around the globe to bring pharmaceutical and biological products to the Australian and New Zealand markets.  Since establishing Pharma To Market, Nick, Jo and their team have successfully managed numerous new marketing authorisation applications on behalf of clients.  Nick’s experience covers a wide range of therapeutic areas and dosage forms, including new chemical and biological entities.  Nick provides his clients with effective regulatory strategies, and often represents clients at pre-submission meetings; he also has hands on experience with orphan drug designation applications and literature based submissions.

Following studies in chemistry, Johanna began her career in the biotechnology industry as a synthetic organic chemist working for a biotech company in the UK. She then relocated to Brisbane, Australia where she continued her career with a local biotech company developing strong HPLC and LC-MS method development and purification skills for a variety of molecules. She later moved to a Brisbane-based pharmaceutical company where she worked in the Quality Control department before transferring into Regulatory Affairs in 2005. In this role Johanna led projects to register generic products in all major markets (AU, NZ, US, EU & CA) working closely with key stakeholders from all departments.

In 2009, Johanna co-founded Pharma To Market providing regulatory consulting, pharmacovigilance and eSubmission services to companies within Australia and worldwide. Over the last 8 years Johanna has led projects resulting in the successful registrations of NCE, NBE, biosimilar and generic products covering a wide range of therapeutic areas and dosage forms. Having spent 3 years as a TGA external evaluator for the Office of Prescription Medicines, Johanna has excellent experience and insight into TGA’s requirements. Johanna also has 10 years’ experience preparing dossiers in eCTD and NeeS format for all major regions and is an official partner of LORENZ Life Sciences Group, developer of LORENZ docuBridge. At Pharma To Market, Johanna strives to build long-lasting relationships with clients and partners, taking time to get to know them and their expectations.

Joelle started her career in the pharmaceutical industry in 2005 as Regulatory Affairs Project Manager for a specialty pharmaceutical company headquartered in Singapore, responsible for in-licensing and marketing of USA and European brands in Asian markets, covering therapeutic areas in allergy & otolaryngology, gastroenterology, obstetrics & gynecology, ophthalmology and radiology. Joelle then moved to a large global pharmaceutical company, well-known for developing biologics, heading the regulatory affairs, pharmacovigilance and quality departments in the Singapore affiliate.

More recently, Joelle was the regional Regulatory Affairs Manager for another fully integrated biotechnology and pharmaceutical global company specializing in the field of immunology. During this assignment, Joelle developed the regulatory strategy for the Asian region, successfully establishing and directing regulatory operations in 13 countries and greatly expanding the market presence of the portfolio of products. With these assignments, Joelle has acquired a vast and diverse experience in key therapeutic areas as well as pre-and post- marketing regulatory activities in various geographical areas in the Asian region. As Director of Pharma To Market – Asia, Joelle coordinates services to companies in the region including regulatory affairs strategy, dossier preparation and submission management as well as ongoing maintenance of marketed products.