Consulting Services

Consulting Services

Our highly-specialised team of technical experts

bring decades of knowledge and hands-on

experience, as well as a high standard

of quality in every project.

Projects
Some of the exciting projects we've worked on
in the past two decades are shown below
New Chemical Entities (NCE) projects
- Prescription Medicines, OTC, Complementaries
- Local development including: New formulation development, reformulation, New delivery systems, Combination products, Enzymes, Stem cell biologics, Phase 2 trials for anti-cancers and pain medications, Monoclonal Antibodies development. Development for TGA, FDA and EMA.
- Literature-based Submissions (LBS) including: Extension of indication, Combination products, Data exclusivity. (Create 2.4, 2.5, 2.7).
- Other areas including: New product (Cat 1) and product maintenance (Cat 3) eCTD submissions to TGA; and Biosimilars, Training, Dossier Due Diligence, SAS supply, Regulatory Strategy Development.
Medical Devices projects
- More than 300 ARTG approved class I, II, III, AIMD, IVD.
- FDA 510K and PMA filing,
- CE Conformity Assessment applications and dossier development (including risk assessment, CER, BER, bench testing)
- Local development including: 3D printed implants, Neuro-electro stimulator, Radiological implants, Software, Eye repair, Retractable syringes.
- Product Maintenance.
- Regulatory Strategy Development and Project Management.
- Training.
Generic Medicines projects
- New product Cat 1 and product maintenance Cat 3 Submissions to TGA, EMA and FDA.
- BE/PK/PD Phase I Trials, Phase III trials (e.g. creams).
- Physico-chemical comparison (e.g. micelles, eye-drops).
- Product Maintenance.
- Products include: Immediate and Modified Release Tablets, Oral Solutions, Sterile Injectables, Infusion bags, Pre-Filled Syringes, Eye drops, Creams, New dosage form (salts, strengths).
OTC and Complementary Medicines projects
- New product and product maintenance submissions to TGA, MedSafe, EMA, FDA and Health Canada.
- Regulatory Strategy, formulation development.
- Process and product development.
- Project management.
Manufacturing and Supply Chain projects
- Sourcing of manufacturing sites and laboratories for product development and manufacturing.
- Design, building, commissioning and acquisition of active pharmaceutical ingredient sites, Johannesburg.
- Development of products and processes in Faulding.DBL/Hospira sterile site, Mulgrave.
- Involved in design, building and commissioning of AstraZeneca sterile site and development of products and processes, Macquarie Park.
- Design and process validation of Complementary medicine site, Melbourne.
- Design and promote services of animal health and clinical trials pharmaceutical steriles, St Marys.
Regulatory Affairs
The SPD Company thrives on tough consulting projects. We bring a unique formula of capabilities and speak with authority on the scientific and regulatory aspects of life sciences product challenges.

Our expertise includes submission, maintenance and regulatory strategies for NCE's, Generic Medicines, Medical Devices, OTC and Complementary medicines covering:

Development of Regulatory Strategy.

Dossier Due Diligence.

Project Management of bench/laboratory testing, animal studies and human clinical trials.

Creation of eCTD dossiers.

New product (e.g. cat 1) and variations (e.g. cat 3) submissions.

Responding to deficiency questions.

System development to manage workflow.

Training.
Product Development
From great ideas all the way to the pharmacy or
hospital, SPD assists you in every aspect of concept development, IP assessment, design, development and manufacturing processes.
How SPD does it

Facilitating brainstorm sessions for concept development.

Assessing intellectual property, access to IP experts.

Designing and developing products and their control tests.

Developing manufacturing processes.

Supporting manufacturing site design and construction.

Validating processes and facilities.

Project managing and implementing optimal new product launch processes, e.g. product portfolio analysis and selection systems development.
Quality Assurance
The SPD Company offers skilled QA experts, helping you upgrade or implement your QMS to
GMP, ISO 13485 or ISO 9001. We also offer
support in internal and external audit
preparation, as well as conducting
audits themselves.

Our expertise includes GMP, ISO 13485, ISO 9001, covering

Development of systems ‘from scratch’.

Upgrade of existing or out-of-date systems.

Internal and External audit preparation.

Conducting and sign-off of Internal Audits.

Training.
Litigation
SPD empowers your legal teams with specialist knowledge and deeper understanding during
litigation proceedings.

More than expert witness services, our team is skilled in:

Providing impartial advice in litigation matters.

Clarifying technical aspects.

Offering expert witness facilities for court cases.
Due Diligence
We provide technical guidance for potential acquisitions of products, manufacturing sites
and/or enterprises, both in Australia
and overseas.

When it comes to Due Diligence and Technical Feasibility, our focus is on

Investigating the robustness of product technology.

Evaluating product integrity and potential as a commercially-viable option.

Assessing the technical and financial viability of the product manufacturing capability.

Technical feasibility and due diligence audits on factories, businesses and products with the aim of clients acquiring or in-licensing them.
Manufacturing & Supply Chain
At SPD, we provide solutions to help
optimise your supply chain and
manufacturing processes.

Our specialists are well-versed in

Undertaking detailed gap analyses.

Addressing inefficiencies in supply chain.

Optimising processes.

Setting up and maintaining supply chain processes.
A Network of Specialists
In addition to our own personnel, through
SPD’s network of specialist technical service providers, we have access across
numerous areas.

Laboratory and bench tests – microbiological, chemical and mechanical.

Pre-clinical and clinical trials.

Reimbursement.

Literature searches.

Statistical analysis.

Advertising material development and assessment.

Manufacturing and repackaging.

Post-marketing monitoring and pharmacovigilance.

Home

Consulting

Services

Training &

Workshops

Testimonials

Contact

theSPDco@bigpond.net.au

linkedin.com/in/clive-simon-spdco

Telephone

0402 546 792

Address

PO BOX 1915 Macquarie Centre NSW 2113 Australia