FAQs

Q?We are a start-up company. Are you able to help us?
A.

Of course! The needs of a start-up company are often different to those of an established company as you are generally starting from a point of having very little, if any, documentation related to your company and product or service.
As specialists in providing relevant documentation, we can start you off with a business plan and strategies for the commercisalisation of your product, including for the establishment of Quality Management Systems, obtaining regulatory clearance/approval for your product in your target markets, and helping with all the documentation and management of a clinical trial.

Q?We are an established company. How can you help us?
A.

As an established company, you probably have a lot of the documentation in place already to ensure your company runs smoothly. If you are introducing a new product, we can provide you with an extra pair of hands to help with the strategy and implementation of bringing that product to market. Alternatively, you might need an independent set of eyes to review and audit your systems.

Q?Where do you provide services?
A.

We can provide services worldwide. We have a network of consultants in a range of specialist areas based in different parts of the world.

Q?How do you charge?
A.

Generally, the charges for our services can be organised in a way that suits you, the client, and the project. Some projects lend themselves to hourly charges, whilst others are better charged on a daily, weekly, monthly or even a project-based term.
Billing is also similarly project-dependent with some invoices sent out immediately the work is completed, and others going out on a monthly basis.
This will all be worked out with you when we discuss your particular project, and we will provide you with a written proposal to suit the project.

Q?We’re a start-up company and not sure where to start, but we know we need some help. Can you help?
A.

Of course! We’ve worked with many start-up companies and can help you work out a strategy that is appropriate for your technology or product. We can develop a commercialisation strategy that covers design and development, validation studies (including clinical trials), manufacturing (including GMP and quality assurance), regulatory affairs in a range of countries, and reimbursement.
If you don’t need all of that, or just want to focus on the smaller picture, we can do that too.

Q?We want to do most of the work ourselves, but need some guidance. Would you offer that?
A.

Of course! In all of the consulting work that we do, our aim is to ultimately step back from your company, leaving you with all the information and skills required to continue the work on your own. If, on the other hand, you don’t feel there is sufficient need within your organisation to warrant having someone in that role, then we are happy to work with you on an as-needed basis to keep you ticking along.

Q?What types of product do you have experience with?
A.

We have experience with most sectors within therapeutics, including: medical devices and in vitro diagnostics; pharmaceuticals, over-the-counter (OTC) and complementary medications; and biologics and biosimilars.