Medical Device & Pharmaceutical Consultants
PharmOut was established in 2006 in Melbourne, Australia, and by delivering value for money and solutions quickly grew to become the region’s largest medical device and pharmaceutical consultancy firm in a very conservative, risk adverse market.
PharmOut offers a broad and comprehensive range of GMP consulting services to manufacturers and product distributors, within the Asia Pacific region, to industry and regulatory agencies. Our Medical Device and Pharmaceutical Consultants work with clients in a broad range of industries from ATMPs, blood and tissue, medical device, pharmaceuticals, pesticide and veterinary manufacturers, as well as related cosmetic, hospital, and pharmacy operations.
Consultants for Manufacturing Operations
Auditors
PharmOut provides on-site or remote auditing services to help you identify and address any gaps in GCP, GMP or GLP compliance standards. Our consultants can develop remediation plans to ensure you are well-prepared for regulatory audits and inspections or preform a mock audit before the regulators arrive.
Consultants
Our internationally experienced medical device and pharmaceutical consultants offer practical expertise in implementing and enhancing Medical Device and Pharmaceutical Quality Systems to meet regulatory requirements. We can help you achieve compliance with ISO 13485 and other applicable standards like US FDA GMP or EU GMP.
Contract Staff
PharmOut can supply a range of QA or experienced GMP contractors at short notice. If you need an extra pair of hands to complete a specific job or even several contractors to support a major project, we can help you by providing some of our well trained and experienced GMP professionals, Architects, Engineers, Scientists, Chemists or Microbiologists.
Designers
From the initial feasibility design to the concept and final detailed design, our expert team of Architects (and Engineers) can ensure the development of world-class health science facility. As well as highly regulated manufacturing sites, that need to comply with Good Manufacturing Practice (GMP) regulations and ISO 13485 standards.
Engineers
Our expert team of process engineers can assist your process development and ensure that you have a world-class health science facility, laboratory, and highly regulated manufacturing sites that comply with international Good Manufacturing Practice (GMP) regulations and ISO 13485 for medical devices.
Temperature Mapping
There’s an increased emphasis by regulators on the need to perform GMP temperature mapping on controlled temperature storage. PharmOut has the equipment and experienced professionals to help you achieve compliance in this area. We can assist with the protocol development, trial execution, data analysis, reporting as well as an ongoing mapping service after the initial protocol development.
Project Managers
PharmOut can offer GMP project managers that can help you get up and running while still complying with the relevant regulations. Our extensive experience in the veterinary, pharmaceutical, biotechnology and medical device industries will ensure that critical compliance issues are on the project plan. The project plan would typically include the physical building and the QMS and Validation.
Technical Writers
Our GMP technical writers are carefully recruited to not only provide you with an experienced technical writer who specialize in writing in plain language but who also bring GMP consulting strength to your project. This means that our writers understand documentation change control and document approval processes in a GMP environment as well as being able to provide broad GMP consulting across a range of subjects.
Validation Engineers
PharmOut is a leading employer of well trained and experienced validation engineers. We can offer validation consultants and/or validation contractors to support you throughout the validation life cycle projects. They will use a risk-based approach to focus scarce resources only on what needs to be validated to ensure product quality and patient safety. These services can be offered on both a fee for service basis and a fixed price basis anywhere in the world.
Why Choose PharmOut?
Training – Classroom, Online and Annual Conferences
Our medical device and pharmaceutical consultants share their experience in wide a range of training options from classroom training, virtual (instructor led), and annual conferences all at affordable prices and with a Google rating of 4.9 Stars!
Classroom Training
We offer a wide variety of specialized training programs including an extensive range of GMP training options. These include classroom, virtual instructor led and online courses (see next tab). Our courses cover a wide range of topics, from PIC/S, EU and FDA GMP compliance, ISO 13485 and 14971 courses for the medical devices. Our public training courses are offered in small groups <15, led by industry trained instructors.
Online GMP Training
We offer a wide range (65) of online GMP training courses which covering an extensive range of GMP training options. This link will take you to our www.onlinegmptraining.com website for more information on our wide range of courses covering diverse subjects for pharma such as data integrity, pharmacovigilance, qualification, validation to medical device courses, i.e. CFR 820 and EU MDR for medical devices.
Pharma & Device Forum™
Since 2011 PharmOut has been facilitating annual conferences on validation, GMP and facility design. It originally started out as the NVF (National Validation Forum), the event grew to become the GMP forum™, we led the discussions on a number of important topics, Pharma 4.0®, medicinal cannabis, in 2024 this will be the Pharma-Device Forum™. For the industry-by-the-industry.
Consulting Services for Product Distributors
Product Registration
If you are looking to supply your therapeutic goods (medicines or medical devices) products into the Australian or New Zealand markets but are unsure on the surrounding regulations, PharmOut’s regulatory affairs consultants will be able to help with your product registration.
Pharmacovigilance
Our pharmacovigilance consultants are a team of well trained and experienced pharmacovigilance professionals complimented by team of regulatory, QA and GMP staff. We can offer a one-stop shop of support services for local and international clients.
Sponsorship
If you are entering the Australian market for the first time, and have not yet found a Distributor, Agent or Sponsor, we can act as interim sponsors so you can obtain a TGA manufacturing certificate before listing or registering your drug or device on the Australian Register of Therapeutic Goods (ARTG).
