About Us

Biotech Regulatory Contact

Biotech Regulatory Solutions is a 100% Australian Owned and Operated specialising in pharmaceutical/medical devices Regulatory Affairs and as well in Pharmacovigilance, Medical Information and Quality Assurance consulting.

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 leading  consultants in their speciality. We have over 90 years combined experience in the pharmaceutical and therapeutics industry. For instance our regulatory affairs consultants have > 15-20 years regulatory affairs experience, so you can be assured that only an experienced regulatory affairs consultant will be working on your project. Our Quality Assurance, Pharmacovigilance and Medical Information consultants have comparable experience. We have all worked in large, medium and small pharmaceutical companies and upheld senior management positions.

We provide strategic advice on the registration and maintenance of prescription pharmaceutical medicines, biological medicines, over-the counter medicines, complementary medicines and medical devices. Our support is full circle from project initiation to life cycle- Regulatory Affairs, Scientific and Medical affairs and Quality Assurance. We are your one stop Regulatory Affairs and Scientific Affairs specialist consulting company.

Regulatory Affairs consulting services

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.

Medical and Scientific affairs consulting services

Biotech Regulatory Solutions provide the following Medical and Scientific affairs consulting services:

  • Prepare Pharmacovigilance audit readiness gap-analysis reports and solutions
  • Provide Medical Information (MI) consulting support services on behalf of Sponsors
  • Provide Pharmacovigilance (PV) consulting support services on behalf of Sponsors
  • Review Promotional Material for compliance with legislation and industry Code of Conduct
  • Provide Quality Assurance (QA) consulting support (Quality Management System develop, SOP development, GMP licensing assistance, vendor audits, wholesaling/distribution consulting services (including State based Licensing), GMP Technical agreements support)
  • Work in collaboration with your company throughout the process and become an integral part of your team.

We are committed to supporting your product on the market and in market readiness activities.

Katy King – Principal Regulatory Affairs Consultant & Managing Director

Member of the following Associations:

ARCS

Association of Therapeutic Goods Consultants (ATGC)

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