Need Product Assessment and Registration?

Australia and New Zealand Regulatory Consulting

Pharmaceutical Solutions has skilled medical research professionals that can provide you with guidance on all aspects of Regulatory Affairs, Quality Assurance, Strategic and Technical Advice and New Product Development in Australia and New Zealand. We provide services to both local and international companies in the pharmaceutical, biotechnology and medical device sectors. We work with you to navigate the different Regulatory requirements of each country so to achieve rapid regulatory approval and market entry.

Our regulatory personnel have extensive industry experience with prescription, OTC, complementary medicines, generic and device registrations and compliance. Our consultants come from a range of backgrounds and understand the challenges, increasing requirements and demands from our respective health authorities. Whether it’s a short term project or long term collaboration, we can advise and deliver to your requirements. 


 Recent Client Feedback

"Thank you very much for your help in getting my products organised from a compliance perspective in New Zealand.

Without your assistance and guidance (and Patience) it would have been a much more stressful and time-consuming affair for us.

Appreciate your time to break everything into plain English for me"

 

Clinical Trial Approvals

  • Clinical Trial Applications – preparation and submission through to approval for Medsafe and TGA
  • We can act as local country clinical trial Sponsor and provide ongoing reporting responsibilities
  • Significant experience with Medical Device and Phase 1 Studies
  • Medsafe / TGA
  • Device NZ

Product Regulatory

  • Product sponsorship with Medsafe (NZ)
  • Product Sponsorship with Therapeutic Goods Authority (TGA) Australia – (Pharmaceutical Solutions is a registered enterprise with the TGA)
  • New product submissions (Rx, OTC, Medical Device, Complementary Medicine, Generic, Biosimilar)
  • Dossier Evaluation and gap analysis
  • Variation and Changed Medicine Notifications
  • Full audits of regulatory files to ensure compliance
  • Promotional material reviews
  • Rescheduling and Reclassification submissions
  • Technical product support and advice
  • Prescribing Information, Data Sheets and Consumer Medicine Information
  • Labeling / artwork preparation and review
  • Section 29 management in New Zealand

Quality

  • QA Consulting
  • Recall and Crisis Management
  • Product Quality Complaint management and resolution
  • SOP development and training
  • Quality System development and audits
  • Product compliance

Health Product Registration 

Examples of Natural Health Products we can register.

  • -Dietary Supplements
  • -Herbal Remedies
  • -Complementary Products/Medicines
  • -Listed Medicines
  • -Holistic Products
  • -Homeopathy Products