One of the reasons we established Pia Pharma was to develop a scientific resource with the capacity to assist anyone from an individual to a multi-national entity to bring chemical product concepts to life. This process begins by assisting clients to define the path to commercialisation, taking into account any statutory or regulatory requirements. We realise you may need to talk through the concept, so to kick start the process we can offer a 1 hour free confidential consultation. You will find us an effective sounding board. Quite often we’ll ask the challenging questions about your concept based on our experience. If you are open to suggestions, we can assist to include value-adds or differentiate your product. Contact us to arrange a suitable time to begin discussions. Use the time before we meet to refine your concept and explore the intended market. We can arrange a non-disclosure agreement to protect the transfer of commercially sensitive information during our discussion. Drop us an email, we’ll get you started.
Pia Pharma’s services span from concept to commercialisation and we can work with you throughout this process, or provide defined service components to complement your existing resources. There may be good reasons to use Pia Pharma, particularly as we are responsive and quite often capable of moving a project faster from outside of the organisation. A good example would be the preparation of stability batches in a GMP facility. Clients may prefer to prepare the batches in their own GMP facility, but contend with production schedules, personnel availability and an inflexible production system for new development materials. Unencumbered by many of these limitations, Pia Pharma can source development materials, qualify processes and equipment and produce stability batches in our GMP manufacturing suite. We can prepare batches for stability in a very short timeframe. This makes a significant difference to the submission time, and ultimately can lead to a reduced time to market.
We are experts in pharmaceutical and agrochemical product testing. This analysis is predominantly based on extraction or dilution and determination using High Performance Liquid Chromatography. Our instrumentation is cutting edge, and we have a suite of detection systems that extends the scope of analytes to include ionophore antibiotics and other molecules that are not done with typical HPLC-UV systems. We can determine active constituents, degradation products, impurities, preservatives, antioxidants and other components in a formulation.
We conduct analytical determinations on a wide range of biological matrices. These include plasma, serum, animal tissues (muscle, liver, kidney, fat), urine, feed, food stuff, fruits and vegetables.
We specialise in animal health and paediatric medicine product development. Our formulation development skill set extends to pharmaceutical, over-the-counter medicines, supplements as well as agrochemicals. Our analytical laboratories can service an even wider section of industry. Contact us with your requirements and questions.
Pia Pharma has a Quality Assurance program that is based on compliance with the requirements for Good Manufacturing Practices (GMP) and the principles of Good Laboratory Practice (GLP). Pia Pharma is licenced under the APVMA Manufacturers Licence Scheme for Category 2 Liquids manufacture, Analytical testing: physical and chemical, Release for Supply and secondary packaging operations. Pia Pharma’s QA program is regularly assessed by external audtiors.
Pia Pharma has implemented a Validation Master Plan to cover aspects of analytical, process, cleaning and computer validation. Our analytical laboratories use analytical methods that have been validated, generally with reference to an international guidance document. A method validation is a rigorous testing process for an analytical method, and the outputs are assessed for conformance with mandated performance criteria. Demonstrating the integrity of data produced is essential for inclusion in documentation for regulatory evaluation and approval.
Yes, we do this routinely. We have strategic partnerships with leading suppliers of ‘in-life’ services. Quite often we coordinate the product supply, study design, quotes, execution, monitoring and reporting for ‘in-life’ phases. We provide analytical support for pharmacokinetic, bioequivalence and residue studies.
Yes, throughout my career I have been involved with over 100 products that have been registered by the APVMA or New Zealand’s ACVM. These ranged from a typical ‘generic’ style to novel therapeutic products. My specialty is taking a therapeutic product desired by a client, and adding additional value. This may be by modifying the formulation to improve absorption, prolong efficacy, add target species, extend claims, or just cheaper to manufacture.
Product registration in Australia is challenging. We have a first-world regulatory system mandated by the Australian people through the government of the day. We have a very well educated consumer base who are increasingly aware of the impact chemicals have on humans, animals and the environment. Add a rapid mechanism of broadcasting customer displeasure through social media and this creates a ‘risk aversion’ paradigm within our regulator.
The Pia Pharma Regulatory Affairs team take this head on. We understand the APVMA process and requirement to address the various statutory criteria. We use well planned and executed scientific studies to generate the required data. We use existing science and literature to support our scientific arguments and present a case that leads the evaluator to the desired conclusion. It is tried and tested…it works.