 |
We are pleased to advise you of "Biotech Regulatory Solutions" consulting business based in Sydney - Australia.
Our company offers a service that is professional, high quality, flexible and solution based to
meet all of your needs.
We have over fifteen years experience in the pharmaceutical industry and ten years in regulatory affairs.
Biotech Regulatory Solutions can provide your company the following regulatory consulting services:
- Prescription Medicines – NCE, line extensions, major variations & general maintenance
- Biotech Medicines – New entities, line extensions, major variations & general maintenance
- Generic Medicines – new generics, bioequivalence study management & general maintenance
- OTC medicines – NMA, variations & general maintenance
- Literature Based submissions
- Dossier review- gap analysis reports
- Clinical Trial support
Do you want someone that hits the ground running and can work in your offices or remotely? Are
you currently recruiting and you need someone to hold the fort during the recruitment process? As an experienced regulatory consultant there will be no down-time, just point us in the direction of our work area and your files. Interstate assignments are also possible.
Do you have a maintenance project that keeps being avoided by your team due to workload
commitments and it just needs 1 day- week of attention to finalise? Biotech Regulatory Solutions expect the un-loved projects! We can come into your office, roll-up our sleeves and focus entirely on your project/s.
Do you have a complicated regulatory submission that needs specialised assistance e.g. literature based submission? We enjoy complicated submissions as they offer the interesting challenges. We have several years experience working on LBS. As an additional service we have a broad range of specialised contacts (e.g. toxicologists, medical writers, ex-TGA evaluators) within the industry should this be requested by the client.
Biotech Regulatory Solutions provide competitive rates, itemised proposals and billing; there will be no surprises. We look forward to the opportunity to discuss your projects and how we can assist you and your team with your regulatory workload.
Yours faithfully,
Katy King BSc (Biotechnology)
Principal Consultant
