Highly skilled. Customer focused. Results driven.

Global Pharma Solutions was founded in 2003. From one person, we have now grown into a team with a combined industry experience of over 115 years. We are driven by the desire to provide you, our client, with personalised support across all areas of Regulatory Affairs, Clinical Development, Quality and Pharmacovigilance for prescription, OTC, and complementary medicines, medical devices as well as cosmetics.

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.

OUR TEAM

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

Chandan Passi

Helen Sutton

Fiona Pollock

Oliver Stokes

Hazel Palmer

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

PRODUCT DEVELOPMENT CLINICAL RESEARCH/OPERATIONS REGULATORY STRATEGY AND PROJECT MANAGEMENT MARKETS FOR REGISTRATION REGULATORY SUBMISSIONS AND LIFE CYCLE MANAGEMENT LITERATURE-BASED SUBMISSIONS RESPONSES TO EXPERT COMMITTEES ONGOING PHARMACOVIGILANCE SUPPORT

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

AUSTRALIAN TGA

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.

UNITED STATES FDA

Advice on accelerated pathways/designations:

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

JAPAN

Cell therapies
Conditional approval

EUROPE

Cell therapies
ATMP classification
Scientific advice meetings

ASIA

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