Pharma To Market is a leading regulatory affairs consulting company operating in the Asia-Pacific region. We assist pharmaceutical, biotech, medical device and other life science companies to register their products and access the diverse and rapidly growing markets throughout Australia, New Zealand and Asia – Singapore, Malaysia, Indonesia, Thailand, The Philippines, Vietnam, Brunei, China, Japan, Taiwan, Hong Kong, South Korea.
Founded by ex-TGA evaluators and industry specialists, Pharma To Market has a unique understanding of the regulatory landscape in Asia Pacific. Pharma To Market’s client relationships are built on trust, transparency and reliability, which we achieve through our commitment to quality and excellence.
We go the extra mile to achieve results and fit in with your time frame and budget. Let us be part of your success story!
To become an industry leader through our commitment to customer service, quality, and current and extensive knowledge in our fields of expertise.
Our culture of professionalism, honesty, openness and respect will enable us to be a reliable and trusted partner for our clients in the pharmaceutical industry, delivering comprehensive regulatory consulting and outsourcing solutions.
Our Management Team
Nick’s career in the pharmaceutical industry began in 1997 and since then his roles have spanned international regulatory affairs and strategy, GxP activities, e-Submissions and laboratory roles in pharmaceutical chemistry and manufacturing.
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.
Johanna has worked in the biotechnology and pharmaceutical industry since 1999 and has specialised in global regulatory affairs for the last 12 years.
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 has over 12 years’ experience in regulatory affairs in Asia working with biotechnology companies and pharmaceutical companies. After completion of her pharmacy studies in Singapore and various hospital assignments.
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.
Relationships with our clients are built on trust, transparency and reliability.
If we think of a better way of doing things – we’ll let our clients know and if we don’t know how to do something, we’ll find someone who can.
Quality and Excellence
We know that’s what our clients deserve and expect. We go the extra mile to achieve results and fit in with our client’s time frame and budget.
We keep up-to-date on changes in legislation, guidance and technology; our clients get the best advice in the most expedient manner.
Quality Management System
Pharma To Market are proud to operate under an ISO 9001:2015 certified quality management system. This certification demonstrates our commitment to provide consistent, high quality services to ensure our customers are satisfied.
We are experienced in GxP auditing and can offer specialised expertise in all areas of compliance and quality assurance. Pharma To Market can provide an independent audit for your business along with tailored support to manage compliance issues.