the SPD company Dr Clive Simon, Principal, The SPD Company.

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1 the SPD company With decades of local and international experience at the coalface, The SPD Company s specialists have built a solid repertoire of in-depth technical knowledge within the highly-regulated pharmaceuticals, medical devices, biotechnology, OTC, complementary medicines and animal health industries. SPD concentrates on Regulatory Affairs, Quality, New Product Development, Supply Chain Logistics & Manufacturing Operations, Due Diligence and Litigation support. SPD s core and contract personnel are highly skilled in the technical and managerial arenas, with many years extensive industry experience. Every project is either personally undertaken, or carefully monitored, by SPD s Principal, Dr Clive Simon. Founded in 2004, our boutique consulting company puts people, systems and skills in place until the need for our services becomes redundant. Dr Clive Simon, Principal, The SPD Company. 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. At the same time, SPD fully understands the business of profitability and commercialisation.

2 Regulatory Affairs SPD specialises in the area of Regulatory Affairs, guiding you through the minefield of regulations and rules within TGA, Medsafe, FDA, EU and Asian regulatory bodies. Advising on regulatory strategy & costing Conducting gap analyses of submission dossiers Generating required documentation Collating submission dossiers and applying for product registration for submission to TGA, FDA and other bodies Streamlining regulatory processes and procedures Evaluating staff skills gaps and mentoring employees where needed Project management As an extension of our GMP and regulatory function, Clive (SPD) is a great sounding board when facing challenging opportunities Technical Manager, Australian home-grown OTC company Specific examples: Prescription Medicines NCE and Generics Cat1 applications, Literature-based Submissions, Cat 3, SAR and SRR variations, All aspects of creating Modules 1, 2 and 3, Regulatory strategy for clinical trials. OTCs New product and variation submissions, Dossier documents creation (CMC and clinical). Complementary Medicines New product submissions, Dossiers created: Labels, Specifications, Table of Clinical Evidence. Medical Devices - Numerous class I, II and III applications, Conformity assessment technical files, reports: Clinical Evaluation, Risk Assessment, Essential Principles Requirements, QMS development: ISO 9001, Biologicals Technical file for haemopoietic progenitor cells, TGO 75 procedures and systems, blood and tissues QMS for GMP audits, biosimilar applications. and general projects undertaken In the Medicines & Devices space: Most therapeutic areas covered, e.g. cardiovascular, anti-depressants, oncology, dialysis. Applications submitted in NeeS, CTD and ectd format. Special Access Scheme applications. PQRs creation. the Clinical Evaluation Labels and advertising/promotional materials. reports that (SPD) generated GMP clearance applications and maintenance. for us were of high quality PBS listing - minor submissions and secretariat QREM Manager, Global pharmaceutical company listings, access to experts for more complex applications.

3 Quality Assurance & Compliance SPD works closely with you and your suppliers in preparing for internal and external audits such as: TGA, GMP, APVMA, EU, FDA, Medsafe, ISO 9001 and ISO Reviewing documentation and processes and moulding these into compliance Developing sustainable QA systems Auditing facilities and Quality Management Systems for compliance Project management On-the-job mentoring where required Specific examples: Systems development of product launch processes and computerised systems validation. Development of post-marketing systems - change control, recalls, pharmacovigilance, sponsor requirements. New Product Development From great ideas to the retail pharmacy s shelf... SPD assists you in every aspect of concept development, IP assessment, design, development and manufacturing processes. 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, eg. product portfolio analysis and selection systems development Supply Chain & Manufacturing Operations SPD provides solutions to help optimise your supply chain processes. Undertaking detailed gap analyses Addressing inefficiencies in supply chain, optimising processes Setting up and maintaining supply chain processes Due Diligence & Technical Feasibility SPD provides technical guidance for potential acquisitions of products, manufacturing sites and/or enterprises, both in Australia and overseas. 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

4 Litigation SPD empowers your legal teams with specialist knowledge and understanding during litigation proceedings. Providing impartial advice in litigation matters Clarifying technical aspects Offering expert witness services for court cases SPD's Dr Clive Simon is a pleasure to work with, and his reports are comprehensive and persuasive. SPD has been a terrific asset in our long-running litigation. Lawyer, Sydney legal firm dealing in pharmaceutical litigation A Network of Specialists In addition to its own personnel, SPD has access to a network of specialist technical service providers in areas such as: Laboratory and bench tests chemistry and microbiology Pre-clinical and clinical trials Reimbursement Literature searches Statistical analysis Advertising material development and assessment Manufacturing and repackaging Post-marketing monitoring and pharmacovigilance I am personally pleased to have SPD on our team & give SPD our highest recommendation! MD, Sydney-based pharmaceutical company SPD provides a number of relevant forums for skills development, primarily through its mentoring programme and its Techgistics series of workshops in the pharmaceuticals and medical devices space. Mentoring Locating talented staff with the right skills set is becoming increasingly difficult in the competitive market for high performers. One strategy to overcome this is to hire people with great potential, but who may be deficient in some or all of the required skills. The mentoring offered by SPD allows these people to be trained as they grow into their roles. SPD offers flexible support whether it be on-site, on-the-job hand-holding to periodic feedback and sounding board sessions either face-to-face or telephonically.

5 Techgistics Workshops The Techgistics Workshop Series was developed specifically to address critical knowledge gaps within these highly technical specialist industries. Our approach is to simulate real-life situations as closely as possible. Your company can experience these workshops in different ways: Open forums which allow sharing of ideas with industry peers, or a closed, company-only forum, either on-site or at an external venue. Techgistics Workshops are available in a number of platforms, namely: Off-the-shelf (ready-to-go) workshops. Partially-customised workshops which are based on an existing topic, with Case Studies relevant to your company situations. Fully-customised workshops typically constructed on a problem area or situation currently experienced by your company. NOTE: SPD has worked internally with local, North American and European clients, as well as with educational institutions such as Box Hill TAFE, UTS and other industry associations to develop workshops that are much-needed within our industry. As a result, SPD is able to offer a wide repertoire of learning themes in the Techgistics Workshop Series, such as: Medical Devices Unplugged - helping minimise the chances of TGA rejection. Dossier Gap Analysis - will your dossier make the cut? Product Development & Launch Processes in a highly-regulated industry. An Intro into Regulatory Affairs, covering prescriptions, OTCs and Medical Devices. Regulatory Affairs for non-regulatory people. How to Create and Review Dossiers to Register Sterile Products. Conformity Assessment Procedures for Medical Devices. Project Management in a technical and highly regulated industry. Planning for Commercialisation. Conducting Due Diligence. Marketing in a highly regulated environment. Supply Chain. QbD. Quality. Drug Discovery - where it all begins. Risk Assessment - a practical how-to guide. (there was) practical information to use and (take) back to the workplace Senior Regulatory Affairs Associate, Medical Device company (the workshop helped) to identify communication gaps between marketing and Reg Affairs Marketing Manager, Sydney-based medical device company