The short version…

  • competence – we have expertise, backed up by a product development and analytical laboratory;
  • confidentiality – we’re independent, professional, integrity means everything, and focused on delivering a positive regulatory outcome for your business;
  • value driven – building quality into submissions, effective communication and responses to facilitate efficiency out of the regulatory process;
  • informed – we are up-to-date with the regulatory pulse through participation in several regulatory and industry forums.

If you are not convinced, read on!

Pia Pharma distinguishes itself through its comprehensive regulatory services which are deeply integrated within our scientific consultancy business built around robust product development and analytical services. Unlike traditional regulatory consultants, Pia Pharma is the only regulatory consultancy to offer a spectrum of services ranging from formulation development to production validation, catering specifically to the regulated health markets of Australia and New Zealand.  For several years Pia Pharma has been a voice for industry within the APVMA Industry Liaison Committee and other industry forums.   Through this Pia Pharma gains current, valuable insight into the APVMA regulatory affairs and manufacture licensing activities, value which we pass on to our regulatory affairs clients.

The company’s capacity for regulatory affairs consulting is bolstered by a team of practicing chemists who possess not only regulatory expertise but also a nuanced understanding of scientific principles derived from formulation chemistry, product stability, analytical chemistry, bioanalysis and residue chemistry. This competency enables them to effectively navigate regulatory landscapes, interpret complex information, prepare high quality application documentation and promptly respond to complicated regulatory enquiries to achieve a positive regulatory outcome in the most efficient manner.

Pia Pharma prides itself on its swift response times to regulatory requests, facilitated by its in-house facilities, state-of-the-art instrumentation, and specialized expertise. This infrastructure ensures the delivery of practical, cost-effective solutions within efficient timelines, value that is unmatched by traditional regulatory consultants.

Pia Pharma is recognised within the industry and regulatory bodies for its high standards, strategic advisory capabilities, and strong scientific advocacy, making it a trusted partner for clients in both animal and human health industries seeking regulatory success in Australasia.

Pia Pharma’s Regulatory services

  • Product registration applications and variations – Australia, New Zealand, South America, EU, South-east Asia
  • Active constituent registrations
  • Australian and New Zealand import permits for chemical products
  • Data requirements for product registration
  • Strategic advice and pre-application assistance
  • Pre-submission application review or data-gap analysis
  • Study protocol drafting and review
  • Study report review to regulatory standard
  • Dossier preparation – chemistry, health (safety and efficacy), toxicology, metabolism, environmental, residue
  • Portal applications
  • Product label preparation and review
  • Responding to scientific or technical regulatory questions
  • Advocating through persuasive scientific and technical writing
  • Interpreting and addressing regulatory risk
  • State poisons and controlled drug wholesale licensing

Contact us anytime to discuss your regulatory needs.