Quality Assurance

Quality Assurance

Expertise in all aspects of Quality Assurance.

We have extensive experience in the development, documentation and implementation of Quality Management Systems to meet the requirements of ISO 9001, ISO 13485, ISO 17025 and ISO 15189.

In addition, we have experience in incorporating the requirements of the US FDA Quality System Regulation (QSR) into management systems that are also compliant with international standards (e.g. ISO 13485).

Thus, if you require assistance with determining a quality strategy most suitable to your needs, as well as establishing a quality management system, or upgrading an existing one, please don’t hesitate to contact us.

We can also provide assistance with other aspects related to a functioning quality management system, such as:

  • Internal Auditing
  • Gap analysis
  • Product and process validation
  • Software validation
  • Risk assessment

Regulatory Affairs

Regulatory Affairs
Regulatory consulting for a range of product types.

Commercialisation of a therapeutic product relies on obtaining marketing clearance or approval from the relevant Regulatory Authority in the country that is the target of the company’s marketing push.

Determining the most efficient and effective regulatory strategy and pathways for your product(s) will be an important part of the commercialisation of your technology.

Our experience extends beyond developing a regulatory strategy and includes obtaining marketing clearance and approval in a number of regulatory jurisdictions, for a range of different types of therapeutic products, including pharmaceuticals, medical devices, biologics, diagnostics, OTCs and others.

Specifically, we can assist you with:

  • Developing a regulatory strategy for your product(s) in one or more markets
  • Australian TGA submissions
  • CE Marking (for the EU)
  • US FDA 510(k) and PMA submissions
  • New Zealand Medsafe submissions
  • Hong Kong Medical device submission
  • Health Canada submissions
  • Preparation of eCTD documentation
  • Preparation of technical files
  • Liaison with regulatory authorities

For information on individual country or region requirements, please refer to the specific information on those markets in our Resources pages or simply contact us.

Clinical Trials

Clinical Trials

Consulting advice on all aspects of clinical trial management.

Clinical trial data is required for many therapeutic products in order to demonstrate the safety and efficacy of the product.

If you are planning a clinical trial, whether it is a small local study or a large multi-site study, and need assistance with the planning and development of documentation required for the study, we can help.

We can assist you with arrange of services, including, but not limited to:

  • Clinical strategy most suited for your technology
  • Planning the clinical trial
  • Writing the clinical trial protocol and other associated documentation
  • Obtaining the necessary ethics committee (HREC/IRB) approvals
  • Clinical trial management
  • Site initiation and management
  • Clinical trial monitoring

Documented Management Systems

Document Management Systems

Documented systems to a range of different international and local standards and guidelines.

Document management systems provide a means by which a company can be compliant with quality management, environmental management, OH&S and a range of other guidelines or standards.

These documented systems provide a means by which compliance can be established and maintained. In addition, document systems can be created that integrate one or more of these management systems into one streamlined system.

We have experience with:

  • Quality Management Systems (e.g. ISO 9001, ISO 13485)
  • Environmental Management Systems (e.g. ISO 14001)
  • Occupational Health and Safety (OH&S) Systems (e.g. AS/NZS 4801, OHSAS 18001)
  • Food Safety Management Systems (e.g. HACCP, ISO 22000)

Medical Writing

Medical Writing
From papers for publication, to marketing brochures, there is much to be written.

Medical writing can take many forms, including scientific or medical writing of papers for publication and abstracts for presentation at conferences, case studies, and other academic literature, and business-specific documentation.

Scientific and medical information will be required for a number of uses and for a wide spectrum of readers, be they professionals or lay persons.

For organisations, medical writing is required for a range of purposes, including for clinical studies, regulatory submissions, literature reviews, marketing information, information memoranda and reporting of studies.

Writing is not just about the actual words or content, but includes the formatting and general presentation of the written word in such a way that it is easy to follow and read and provides the required information in a clean and concise manner.

So, whatever your medical communication needs, contact us for a confidential discussion on how we can assist you.

Business Writing

Business Writing
Start with a business plan and grow your company from there.

For any company, the start usually includes the development of a business plan to document what is known and what is expected or forecast for the development of the business over the short-medium and longer term.

In addition to the business plan however, most businesses will require a range of documents that are intended for internal use only, for external stakeholders, or for a combination of both.

Internal documents might include formal policies to provide guidance within the company, marketing plans, strategic plans, HR manuals etc.

Similarly, documents intended for external parties might include information memoranda, prospectuses, website pages, user manuals for products, MSDSs and other similar documentation.

Whatever your needs, the chances are that we have written something like it before, so please don’t hesitate to contact us to determine how we might be able to assist you.

Grant Applications

Grant Applications

Take advantage of any opportunities that provide the potential for a little extra funding.

Whether you are in Australia, Asia, Europe or the US, many governments and other organisations provide grants or other funding assistance to start-up and even more established companies. For all of these, a case must be made to demonstrate why your technology and your company is worthy of these funds.

This often requires the writing of submission documents to describe your business and your technology in lay terms, and to demonstrate how the funds will be used to advance your company and subsequently provide local benefits in the form of additional jobs or other benefits that a government might consider a worthwhile return on their investment.

The time taken to write these submissions can be quite prohibitive for a company in the midst of commercialising its technology, so contact us for chat on how we can take on the project for you, freeing up your time for other things.

Desktop Research

Desktop Research
Desktop research for all your needs.

Need some background research done on a particular topic or perhaps need to send out a survey to gauge feedback? Whatever your desktop research needs, we can help.

We’ve conducted a variety of research projects for a range of different organisations, including, but not limited to:

  • Background research papers on an area of interest
  • Online or paper-based surveys
  • Focus groups to investigate and discuss topics of interest
  • Business Cases

Whatever your needs, contact us for a confidential discussion of what you need and how we can best help you to gain the information you need.

Commercialisation Strategy

Commercialisation

Expertise in all elements of the commercialisation process.

Our expertise ranges from early laboratory research through to prototype development and testing, clinical trials and regulatory submissions, through to transfer into manufacturing and then marketing. The commercialisation pathway rarely comprises discrete steps as each phase will blend into the next and with many activities occurring concurrently.

This makes the commercialisation of every technology a unique and exciting challenge, and one which requires careful planning to make the process as efficient and effective as possible.

Let us assist you by providing you with our experience and knowledge of the overall process and the specific activities that will be involved. Please don’t hesitate to contact us for a confidential discussion of how we can assist you.

Training

Commercialisation
In-house or external training provided to large or small groups.

Whether you wish to train your staff in a small group setting, or if you need to organise a larger training session for a broader audience, we can help you.

Our training has included:

  • In-house small group training tailored for companies
  • Large group training of a more general nature
  • Multi-day training courses for more in-depth knowledge
  • Short seminars providing generalised overviews of requirements and processes
  • Presentations to Boards to provide information on the commercialisation process

Sponsorship

Sponsorship

Sponsors and Agents for when you need a local presence.

Part of the commercialisation process of a new technology generally involves extending your reach into international markets where you may not have a physical presence.

In some jurisdictions, such as the US and the EU, a local presence is required and this can be achieved with minimal effort through the use of a local agent.

QRC Solutions can act as your local representative in Australia. We can undertake this role in an interim capacity until you establish a presence either directly or through a formal distributor arrangement, or on a more permanent basis to allow you more flexibility.

For other regions, we can assist you to find local representation that fulfils all the requirements of that market.

Whatever your needs, contact us to see how we can assist directly or point you in the direction of some trusted networks.

Global Networks

Global Networks

Worldwide network of experts at your fingertips.

No matter what your background, skills and experience, no-one can be an expert at everything.

That is why we have built an international network of experts in different facets of the commercialisation process so that we can offer you the best of advice from those that are the best in their field. So, no matter what expertise or contacts you need, contact us to put you in touch with the people that know how best to help you.