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.
& Supply Chain
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.
Some of the exciting projects we've worked on
in the past two decades are shown below
New Chemical Entities (NCE) projects
Medical Devices projects
Generic Medicines projects
OTC and Complementary Medicines projects
Manufacturing and Supply Chain projects
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.
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.
Setting up and maintaining supply chain processes.
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Upgrade of existing or out-of-date systems.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.
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.
SPD empowers your legal teams with specialist knowledge and deeper understanding during
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.
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.
Advertising material development and assessment.
Manufacturing and repackaging.
Post-marketing monitoring and pharmacovigilance.
0402 546 792
PO BOX 1915 Macquarie Centre NSW 2113 Australia
© 2017 The SPD Company Pty Ltd. All rights reserved.