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Weir Regulatory Consulting Services

Regulatory Strategy 

At Weir Regulatory Consulting, from the time our Regulatory Affairs consultants first receive a dossier, our focus is the preparation of a quality Regulatory submission, to ensure a smooth evaluation process with the TGA (Australia) or Medsafe (New Zealand), in order to gain Regulatory approval with maximum efficiency and minimum cost.

Where required, our Regulatory Affairs consultants carry out an in-depth dossier review or gap analysis, in order to determine the Regulatory submission category, fees and TGA approval timelines. A TGA pre-submission meeting can be arranged by our consultants to facilitate this, where appropriate.

It is the aim of Weir Regulatory Consulting to ensure we give your Regulatory project the focus it deserves in order to drive your project forward with efficiency.

These Regulatory Affairs consulting services can be carried out by our consultants for prescription only medicines, over the counter (OTC) medicines, medical devices and drug-device combinations, for the pharmaceutical or medical devices Industry in both Australia and New Zealand. 

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Regulatory Submissions

At Weir Regulatory Consulting, our experienced Regulatory Affairs consultants can help plan, prepare and submit both major and minor Regulatory submissions to the TGA (Australia) and/or Medsafe (New Zealand), for various Regulatory submission types for prescription only medicines, over the counter medicines (OTC), medical devices and drug-device combinations. This includes, but is not limited to, New Chemical Entity (NCE), New Biological Entity (NBE), Literature-Based submissions (LBS), hybrid submissions, orphan drug registration, other Category 1 applications, and medical device registration including conformity assessment and reclassification, in both Australia and New Zealand.

Our Regulatory Affairs consultants can also submit post-approval variations such as Category 3 applications, labelling changes, safety related requests (SRRs), self-assessable requests (SARs), and import permits including AQIS and controlled substances.

We can also assist with Regulatory planning, administrative and labelling changes associated with the merger and acquisition of pharmaceutical or medical device companies, and also variations resulting from technical transfers and changes to manufacturing sites.

These Regulatory Affairs consulting services can be carried out by our consultants for prescription only medicines, over the counter (OTC) medicines, medical devices and drug-device combinations, for the pharmaceutical or medical devices Industry in both Australia and New Zealand.

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Quality/GMP

At Weir Regulatory Consulting, our experienced Regulatory Affairs consultants can assist with the review and preparation of manufacturing documents, in order to gain GMP clearance from the TGA for overseas manufacturers and manufacturers based in Australia.

From a Regulatory Affairs perspective, our consultants can also assist with technical transfers and manufacturing site changes, both in Australia and overseas, as well as the review of processes and standard operating procedures (SOPs).

These Regulatory Affairs consulting services can be carried out by our consultants for prescription only medicines, over the counter (OTC) medicines, medical devices and drug-device combinations, for the pharmaceutical or medical devices Industry in both Australia and New Zealand.

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Labelling and Promotion

At Weir Regulatory Consulting, our experienced Regulatory Affairs consultants can review and advise on pharmaceutical promotional items and the advertising of medicines. This is carried out in line with Guidelines published by the appropriate Industry bodies such as the Medicines Australia Code of Conduct, in order to meet ethical marketing and promotion standards.

Our Regulatory Affairs consultants can also prepare, review or revise labelling documents for the pharmaceutical and medical devices industries. These may include Product Information (PI), Consumer Medicines Information (CMI) and mock ups, in compliance with the Regulatory requirements of the TGA (Australia) or Medsafe (New Zealand).

These Regulatory Affairs consulting services can be carried out by our consultants for prescription only medicines, over the counter (OTC) medicines, medical devices and drug-device combinations, for the pharmaceutical or medical devices Industry in both Australia and New Zealand.

Click here for a full list of services