About Us

Pharmaceutical regulatory affairs consulting businessBiotech Regulatory Solutions is a 100% Australian Owned and Operated pharmaceutical regulatory affairs consulting business.

Biotech Regulatory Solutions is based in Australia with consultants in most major cities. Our business provides a service that is professional, high quality, flexible and solution based to meet all of your needs. We specialise in the Australian Therapeutic Goods Administration (TGA) and New Zealand Medsafe requirements and keeping up to date with ANZTPA.

All of Biotech Regulatory Solutions consultants are senior and experienced regulatory affairs consultants. We have over fifty years combined experience in the pharmaceutical industry. Each of our regulatory affairs consultants have > 10 years regulatory affairs experience, so you can be assured that only an experienced regulatory affairs consultant will be working on your project. We have all worked in large, medium and small pharmaceutical companies and upheld senior management positions.

We provide strategic advice on the registration of prescription pharmaceutical medicines, biological medicines, over-the counter medicines, complementary medicines and medical devices.

Biotech Regulatory Solutions provide the following regulatory affairs consulting services:

  • Review chemistry/pharmacy, preclinical and clinical texts and prepare gap-analysis reports
  • Liaise with industry experts when required e.g. medical writers, preclinical experts, biopharmaceutical experts, librarians
  • Prepare regulatory submissions – from new medicine authorisations and support projects throughout the life the life-cycle of your product
  • Prepare your marketing authorisation applications for submission, validation phases and support throughout the TGA and  Medsafe evaluation process
  • Submit dossiers and if required pay fees on your behalf
  • Work in collaboration with your company throughout the process

We understand both the commercial aspects and the unmet medical needs of your medicine/device and we are committed to getting your product to the market as soon as possible.

Katy King – Principal Regulatory Affairs Consultant & Managing Director

Member of the following Associations:

ARCS

Association of Therapeutic Goods Consultants (ATGC)

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