What some of our clients have to say about Biotech Regulatory Solutions:
Katy and Theresa led and managed a complicated literature based submission to the TGA on our Company’s behalf. Their ability to effectively liaise with our Corporate regulatory team while providing the necessary support and guidance to our local team ensured the project progressed through the critical milestones in a timely manner. Their often demonstrated well established and professional relationship with the TGA was a key factor in the project’s success. Theresa as the regulatory lead was the key driver and delivered a great outcome as our Company received registration of this critical product in 2016 for all indications sought.
Technical and Regulatory Affairs Manager – Australian Affiliate of Global Company
Biotech Regulatory Solutions provide our company with a complete out-sourced regulatory, pharmacovigilance and medical affairs solution. Katy and her team bring to our company a high level of expertise and professionalism, acting seamlessly as if they were internal employees. They quickly won the deep respect of our international colleagues for their thorough understanding of the nuances of working in the Australian regulatory environment. BRS have impressed us by securing TGA approvals for key products on time and under budget. Most importantly, they are pleasures to work with; open, transparent, pragmatic, and focused on finding solutions. I recommend their services without reservation.
Managing Director, Australia & New Zealand Global Pharmaceutical Company
We undertook several ‘straight forward’ projects, which inevitably turned into a regulatory minefield. The presence of Biotech Regulatory was a real asset during these times. They have a common sense, pragmatic approach coupled with an in-depth knowledge and relationship with the TGA, which allowed us to achieve our goals and establish our business here in Australia. We will continue to use their services on an ongoing basis.
Regulatory Affairs Manager, Australian Affiliate of EU Company
Biotech Regulatory Solutions have provided us not just with a successful TGA registration, but they have also been an integral part of the team – proactively suggesting ways to enhance and add to the file and add value to the Australian team. Their positive and friendly approach with our team, as well as the TGA also means they have been an absolute pleasure to work with. The obvious pride in their work, and their unabashed joy as we passed positively through each stage of the process made me realise that Biotech Regulatory Solutions are a company that really ‘lives’ their work and I would recommend them without hesitation.
CEO, EU based biotech company
I have had the pleasure of working with Katy and Theresa on a biosimilar project, and consider them to be experts in their field. They carefully navigate through regulatory requirements to provide valuable advice and direction, demonstrating their experience and commitment to the objective at hand.
Director Regulatory Affairs, International Pharmaceutical Company
“Katy and her team have provided us with regulatory affairs consulting services for several years. During that time we have always felt that our business was a priority. The breadth of knowledge of Katy and her team, as well as knowledge of responsible persons at the TGA have always meant our applications have been handled in a professional manner in the least possible time. I would recommend Biotech Regulatory affairs without any reservations to any party seeking an expert regulatory team at a reasonable cost with personalised service.”
Managing Director, Australian Owner Generics Company
“We are very pleased with Biotech Regulatory Solutions and the quality work that they undertake on our behalf. They have an excellent relationship with the TGA which is an invaluable asset when they are working on our business.”
Marketing Manager, Pharmacy Services Company
“It has been a pleasure working with Biotech Regulatory Solutions. Their insight into the regulatory affairs environment in Australia has been a valuable support to us. We have found their expert advice on complex matters to be quite accurate and dependable. Katy and her team are thorough professionals- always meeting the commitments and timelines. They have in-depth knowledge in specialized areas of regulatory submissions and at the same time an approachable and friendly disposition.”
Regulatory Affairs Manager, Overseas based company with new Australian affiliate
“The most challenging part of regulatory is not only finding people who are technically competent, but those who can think outside the box and provide successful regulatory affairs strategy. In this regards, Katy and her team at Biotech Regulatory Solutions have been a critical team to our commercialisation efforts in Australia. They really work as part of our team and will go that extra mile….”
Vice President Asia Pacific (EU based pharmaceutical company)
“We consider Biotech Regulatory an asset to our company. Biotech’s knowledge and experience has given our company the time to focus on the other important aspects of our day to day work; as we are rest assured that the changing regulations are advised to us and further acted upon. Biotech’s expertise and professional relationship has been a great advantage to us, in receiving prompt advice and approvals from regulatory authorities”.
Director, International based Pharmaceutical Company, Australian Affiliate.