Global Pharma Solutions is partnering with companies globally and is actively involved in COVID-19 market authorisation support.

Client relationship is the foundation of our business.


For 17 years, we have managed projects on behalf of our clients. These include small ad hoc projects, high throughput work, large extensive projects involving the development and registration of innovative medicines across multiple markets.


Our unique value add is that we have built and continue to build strong, long lasting relationships with our clients. These relationships are based on trust and proving ourselves in achieving (and exceeding) the desired outcome.


We are here for you - to support, to lead, and to always add value. We guide you through the numerous and sometimes complex requirements involved in getting medicine to patients who need it most. You can see our team’s capabilities below, this is not an exhaustive list, but rather a taste of the value we can add to your organisation. Our team members each have 10-20 years' experience in the industry.

Margaret Jenkins

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Chandan Passi

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Helen Sutton

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Fiona Pollock

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Oliver Stokes

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Hazel Palmer

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A team of specialists holding significant expertise in the pharmaceutical industry with backgrounds in:

  • Strategic planning
  • Drug discovery and drug development
  • Stem cell therapy development (including RMAT designation and ATMP classification)
  • Analytical testing
  • Project management
  • Auditing
  • Literature based submissions
  • Due diligence/gap analysis
  • IND writing
  • Orphan drug designations
  • Vaccines (including annual strain updates)
  • CMC, clinical and non-clinical
  • Medical writing
  • Regulatory writing (Module 1-5)

A team with diverse and deep experiences for clients to draw on. We have experience managing clinical trials and pharmacovigilance.

Our team is experienced in setting up and running clinical trials. We can also advise and support you through the requirements for BA/BE studies, efficiently so no time or money is wasted.

A team of device specialists who have worked on medical devices/IVDs for small and medium device innovator companies, with consistent success.

Our expertise

We develop pharmaceutical products from bench through to registration and market launch. We are trusted partners for many companies ranging from major multinational organisations to smaller start-up companies.

We work closely with you, adding value to your product development process and achieving the best outcome for your new product pipeline. Our experienced team can support you with product development and registration across numerous areas, including:

  • Cell therapies
  • Prescription medicines
    • Small molecules
    • Biologicals
    • Biosimilars
    • Orphan products (including orphan designations)
    • Generics, complex generics
    • Medical cannabis
  • Devices
  • OTC and complementary medicines
  • Cosmetics

  • We help with clinical operation strategies, setting up and running clinical trials
  • We advise and support through the requirements for BA/BE studies
  • We have Quality Management Systems supporting ICH guidelines
  • We develop and write key clinical documents such as Study Protocols, Investigator’s Brochures, etc.
  • We do ethics submissions
  • We do complete clinical program management


We listen so that we fully understand your strategic goals and provide unique and valuable support in the following areas:

  • Regulatory due diligence and gap analysis
  • Australian Product Information (PI) – writing and reformatting to SPC format
  • Australian Consumer Medicine Information (CMI) – writing and reformatting
  • Dossier evaluation/ due diligence/ gap analysis
  • Pre-submission agency meetings
  • Complete dossier writing across multiple countries including Australia, New Zealand, US, UK, EU and Asian region
  • Clinical strategies
  • Non-clinical strategies
  • Medical writing
  • Bioequivalence strategies and biowaivers


Strategies involving innovative/accelerated evaluations, including but not limited to:

  • ACSS
  • COR (comparable overseas regulator) strategies
  • Priority review
  • Provisional approval
  • Orphan Drug Designations

We also offer support for complete post approval life cycle management, integration work (following mergers/acquisitions), supply management, recalls management, compliance and high throughput projects, and project management across all projects.


Advice on accelerated pathways/designations:

  • Breakthrough therapy
  • Regenerative Medicine Advanced Therapy (RMAT) designation
  • Fast track
  • Accelerated approval
  • Priority review


  • Cell therapies
  • Conditional approval


  • Cell therapies
  • ATMP classification
  • Scientific advice meetings


  • Dossier adaptation in line with ASEAN CTD requirements
  • Preparation (or translation) of local labelling and artwork
  • License holding support


We provide support from initial application form submission through to approval including:

  • Responding to agency questions
  • Responding to expert advisory committees and clinical, non-clinical evaluation reports
  • Advice and support on gaining the optimal label for your product

We provide complete life cycle management support to maintain compliance and maximise the value of your product and product families including:

  • Review of changes for regulatory impact
  • Post approval variations (compliance and maintenance)
  • Line extensions (new dose form, route of administration, delivery systems etc.)
  • Extension of indications
  • New trade names/clone applications

In Australia, the TGA process for literature based submissions (in place of, or in addition to clinical trials) is quite unique and requires discussion with and approvals from the TGA before submission of your application. We can support and navigate your application through this process.


We are highly experienced at responses to expert advisory committees and can support and guide you through this process.


We provide support with pharmacovigilance activities ensuring you meet your regulatory obligations, including:

  • Adverse event reporting as per regulatory guidelines
  • Ensure all potential adverse events or product complaints are reported and followed-up according to client procedures
  • Process and report safety data as per SOPs and client instructions in order to maintain client and regulatory compliance
  • Maintain the integrity of client safety data registered into GxP databases and associated paper-based systems
  • Prepare project reports and track agreed KPIs to meet project deliverables
  • Participate in internal and external audits, where necessary



If you’d like to find out more about our compliance rescue contact us for an initial discussion.

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