Regulatory Affairs Consultants

PharmOut are regulatory affairs consultants, specialising in the Australian TGA's requirements can answer your questions.

We offer advice on registration strategies to the medical device, pharmaceutical, complementary medicine, dietary supplement and food industries.

Drug Registration

PharmOut can:

Review chemistry/pharmacy, preclinical and clinical texts
Prepare regulatory submissions
Prepare marketing authorisation applications
Submit dossiers and pay fees on your behalf

Our regulatory affairs consultants can assure validation of the dossier, receive questions from the TGA and prepare suitable responses on your behalf, with your approval.

Our consultants can co-ordinate the submission of responses and provide expert reports/overviews.

Medical Device Registration

Our regulatory affairs consultants can advise on:

CE Marking

Product classification

Preparation of technical files

Risk assessments

Quality audits

Our regulatory affairs consultants offer wide-ranging services relating to medical devices and in vitro diagnostics as well as medicinal products.

We can provide advice on product development, preclinical and clinical research, regulatory affairs and quality assurance.

R&D programmes for novel products

We can assist with planning R&D programmes for novel products; designing suitable studies to meet regulatory requirements and achieving timely approvals in the countries of interest.

cGMP, QSR, ISO 9000, ISO 13485 audits of companies, their suppliers and subcontractors can be undertaken by our lead Auditor, ensuring that the appropriate standards of quality are met.

CE Marking of medical devices

Medical device registration in the European Union is now harmonised with four directives in force:

Medical Devices Directive

Active Implantable Medical Devices Directive

In Vitro Diagnostic Medical Devices Directive

Electromagnetic Compatibility Directive

Products bearing the CE mark can be freely marketed in all member states with little further control.

The importance of achieving timely CE marking cannot be overemphasised. Firstly, we will classify your product to determine which legislation applies, and advise on the optimum route to the market.

We can assist with:

Preparing technical files & essential requirement documentation
Undertaking risk assessments
Preparing for conformity assessment
Recommending which of the many Notified Bodies best suits the situation, acting, if required, as the point of liaison.
Achieving successful regulatory approval the first time around.

Our team can advise on regulatory, scientific and quality matters, including ISO 13485, FDA QSR 820 and related standards.

We can support many types of medical devices: from active and non-active devices, including sterile and electromedical products, to in vitro diagnostics as well as drug-device combinations and borderline products.