Nicole Clarke has a wealth of regulatory experience combined with a commercial perspective which will support the registration of your product. With 22 years in the industry, not one of Nicole’s TGA or Medsafe applications have been rejected.

Nicole has worked in a variety of regulatory affairs roles in the pharmaceutical sector, across a range of product portfolios and dosage forms in both prescription and non-prescription medicines. Having worked with a range of large, small and start-up pharmaceutical companies, Nicole has assisted them to grow to their potential, whilst minimising approval times and expenses.

During her time in the pharmaceutical industry, Nicole has become familiar with the preparation of submissions for biological, OTCs, generics and NCE medicines, and the subsequent evaluation by Medsafe and the TGA.

Nicole has successfully submitted multiple Category 1 applications to the TGA in both eCTD and NeeS format and has undertaken pre-submission meetings and pre-submission correspondence with the TGA to ensure a positive outcome. She has a proven track record in challenging the guidelines where required.

In addition, Nicole closely follows updates in the legislation and TGA guidelines for product registrations, variations and the GMP requirements.

Nicole has developed working relationships within the TGA, and also externally for additional activities including laboratory analysis, clinical trials and artwork preparation as required for your product.

 

What type of products does Regulatory Approval Services specialise in?

These include but are not limited to:

• Injectables and other sterile products
• Tablets
• Capsules
• Liquids, suspensions and solutions
• Powders
• Inhalation products
• Creams, ointments and gels
• Combination products

 

What activities does Regulatory Approval Services perform?

Regulatory Approval Services offers expertise in:

• New Medicine Applications including NCEs, prescription medicines, OTCs, generics and biological medicines
• GMP maintenance
• Category 3 applications
• Line extension applications
• Dossier review and detailed deficiency reports
• Literature based submissions
• Responses to TGA requests, including justifications and biowaivers
• Risk management plans
• Orphan drug designations
• Regulatory maintenance projects
• CMNs and other notifications for both the Australian and New Zealand authorities.
• Import, antibiotic and AQIS permits

 

How does Regulatory Approval Services operate?

Regulatory Approval Services is managed from either a remote location or on-site, which can hit the ground running.

Regulatory Approval Services is a reliable and flexible service which adheres to the strict deadlines of this industry whilst being a cost effective solution with high quality and professional results.

We offer itemised proposals and billing based on competitive rates.

Next time you need a Regulatory Affairs consultant, please call Regulatory Approval Services Pty Limited.

 

 Regulatory Approval Services Pty Limited for regulatory results on time every time.