BioRegulatory Consulting | Regulatory Affairs Consultant | Pharmaceutical & Biotech

Do You Need a Regulatory Affairs Consultant
That You Can Rely on?

There are times when you require the help of regulatory consulting services.

Naturally, you want specialists with a proven track record. Bioregulatory Consulting has written applications for submission to the Australian Therapeutic Drug Administration (TGA) and to global drug authorities such as the Food and Drug Administration (FDA).

Your organisation might be

●	a large pharmaceutical company needing contract work in times of high regulatory work volume OR
●	a biotech start-up or university consortium requiring guidance or advice

Bioregulatory Consulting can provide regulatory guidance in the drug development and registration process and can assist with the design of a cost-effective and streamlined development program.

Click the x-ray image to read an abstract on
Enbrel in the treatment of Rheumatoid Arthritis.
Email to request the full length article.

Regulatory advice from proof of principle through to clinical development, registration and post-marketing activities

Do you need help with the development and registration of human therapeutic medicines? A number of services to meet all your regulatory requirements are available.

We specialise in biopharmaceutics, but our areas of expertise are broad. Ask us about any of the following classes of drugs and devices.

● DNA vaccines
● recombinant viral vectors
● monoclonal antibodies
● prophylactic and therapeutic vaccines
● biosimilars
● generics
● recombinant proteins
● blood products
● medical devices
● diagnostics