SERVICES

Bio Tech Regulatory ServicesSERVICES

Biotech Regulatory Solutions can provide your company
the following consulting services:

Medicine Applications

  • Prescription medicines – New Chemical Entity, line extensions, major variations & general maintenance. Including literature based submissions.
  • Biotech medicines – New entities, line extensions,
    major variations & general maintenance.
  • Generic medicines – New generics, bioequivalence
    study management & general maintenance.
  • OTC medicines – New Medicine Applications, New
    Generic Applications, clone applications, variations
    and general maintenance.

Medical Devices (Class I- III)

Literature Based submissions

Dossier review-gap analysis reports

Pre-Submission meetings with the TGA

Liaison with the Authorities

GMP matters (Licensing, clearances)

Clinical Trial support

Common scenarios

You want someone that hits the ground running with your project. You are currently recruiting and you need someone to hold the fort during the recruitment process. As experienced regulatory consultants there will be no down-time and your project will be up and running.

You have a maintenance project that keeps being avoided by your team due to workload commitments and it just needs some focussed attention to finalise. Biotech Regulatory Solutions expect the un-loved projects! We can roll-up our sleeves and focus entirely on your project/s.

You have a complicated regulatory submission that needs specialised assistance e.g. literature based submission/biolographic submissions (LBS). We enjoy complicated submissions as they offer the interesting challenges. We have several years experience working on successful LBS through the TGA evaluation process. 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.