www.pbcbiomed.ie

Partnering with medical device, biologic and pharmaceutical innovators in supporting their products through the product lifecycle stages.

Accelerating Medical Innovation

PBC BioMed was founded in 2010 to develop and support innovation in the Med Tech area by helping clients accelerate commercialisation of ideas. Working with a broad spectrum of clients, from concept to post marketing compliance, PBC BioMed has helped global clients achieve and maintain CE, FDA, EMA, TGA registrations and reimbursements.

Our Vision: To Accelerate Medical InnovationWe partner with small (including start-ups), medium and large sized med-tech ventures to fast track their innovations for use in hospitals for the benefit of patients and healthcare systems. We are ideally located in Ireland, a major global medical device and pharmaceutical manufacturing and R&D hub, we can also provide access to the all EU

markets and to a wide array of local contract services. PBC BioMed’s team provide support for most clinical areas and is especially experienced in developing and marketing orthopaedic, orthobiologic and combination products and so can add value to ventures focused in the orthopaedic clinical area.

Our Mission Be recognised as the preferred EU partner for accelerating medical innovations to approval and launch so they can make a meaningful difference to patients’ lives and healthcare systems.

Our Values Knowledge Extensive knowledge of R&D/engineering, consultancy, contract manufacturing and commercialisation.

Passion Our vision of ‘Accelerating Medical Innovations’ is what drives our passion.

Excellence We strive to be world class at all times in our beliefs, our ways of thinking.

Responsiveness Proven capability of quick response, accelerating projects to launch.

Integrity We do what we say we will do and do so with a transparent honesty.

Innovation Helping create and bring to market products that provide real value.

CONTRACT MANUFACTURING & SUPPLY CHAIN SUPPORTOur ISO approved facility, including Class 8 Cleanroom, offers assembly and packaging of Medical Device products. In addition, we offer a full Supply Chain service including Customer Service, Storage and Distribution design specifically to meet Client’s needs.

CONSULTANCYOur in-house team and global network of technical experts provide consultancy for Pharma and Medical Device Companies across all areas of the business. PBC BioMed offers Quality Management System development and implementation, Regulatory strategy execution and Post Marketing vigilance for both Medical Devices and Medicines. Our unique resource and location allows us to act as European Authorised Representatives for both Pharma and Medical Device companies looking to commercialise products in the European Union.

R&D/ENGINEERINGPBC BioMed partners with Clients to Design (including product and process) and Develop (prototyping) Medical Devices in line with the Medical Device Regulation. Our Design and Development process is tried and tested by various Notified Bodies and is focussed on achieving the most efficient path to Regulatory submission.

COMMERCIALISATIONPBC BioMed accesses a Global Network of Distributors working closely with the Client to match the needs of new product introductions, reimbursement and Key Opinion Leader access and development. PBC BioMed also offers a direct to customer service in Ireland and the UK.

Our extensive knowledge and expertise combined with experience in product commercialisation has made PBC BioMed a strategic partner for start-ups to highly successful Blue Chip companies. Our key focus areas include:

R&D/ Engineering

ConsultancyCommercialisation

Contract Manufacturing &

Supply Chain Service

Our Services

PBC BioMed support the design, development and validation of medical device, biologic and combination products by leveraging its in-depth clinical expertise, market knowledge, surgeon KOL network and technical capabilities while achieving regulatory and QMS compliance.

IP Commercialisation Establishing proprietary market advantage

Protecting core technology & business methods

Boosting R&D branding effectiveness

Anticipating market & technology shifts

Building R&D Pipeline Optimizing core technology

Road mapping

IP analysis

Identifying key technology enablers

Analysing future market trends

PBC BioMed Can ProvideSkilled Personnel: Experienced engineers and scientists in developing medical devices, biologics and combination products.

Cleanroom Facilities: Access to ISO Class 8 cleanroom certified to ISO 13485 for clinical and pilot scale manufacturing and early stage process development.

RA/QA expertise: Comprehensive RA/QA expertise to ensure regulatory compliance.

Global Network of Expertise: A network of orthopaedic surgeon KOLs to provide input into product design and development.

Service Contractors: Access to wide range of service contractors in Ireland, a global hub for medical device and pharmaceutical R&D and manufacturing.

Services R&D/Engineering

Why Choose PBC BioMed Our support enables companies to focus their expertise on what they do best whilst leaving their regulatory and quality commitments to consultants who can ensure cost effective implementation and ongoing management of compliant RA/QA and Vigilance systems.

Regulatory Support PBC BioMed’s regulatory support includes:Defining the regulatory requirements and

pathways for new devices and medicinesPreparing and updating of technical filesManaging Clinical evaluationUndertaking PSUR for medical devicesUndertaking PMS for medical devicesSupporting scientific advice

pathways for medicinesPreparing for certification auditsActing as local point of contact for Notified

bodies and Competent AuthoritiesMaintaining mandatory technical files

(CE)/Marketing AuthorisationManaging regulatory affairs in new marketsResponding to vigilance issues, Warning

Letters and Notified Body audit findingsComplaint handling, contract

review and surveillance auditsReviewing corrective actions and

recommendation for resolutionActing as Marketing Authorisation

Holder in EuropeActing as Authorised Representative in Europe

Quality Assurance Support PBC BioMed’s QMS support includes:

Design control and documentationRisk managementDesign verification and validationProcess validationStaff QMS training QMS and supplier audits

Pharmacovigilance/ Device Vigilance Support For companies wishing to outsource their Vigilance system PBC BioMed offers a very comprehensive pharmacovigilance and device vigilance service.1 Vigilance System set up2 EU Qualified Person for Pharmacovigilance

(QPPV) including PSUR and Risk Management for medicines

3 System Master File4 Training 5 Audits6 Literature Review7 Case Management8 Signal Management9 Documentation Management

Contact us today to see how PBC BioMed can help you achieve RA/QA compliance more quickly and cost effectively.

Many healthcare companies are choosing to outsource some of their regulatory affairs and quality assurance requirements to ensure compliance and to accelerate implementation in today’s fast changing and increasingly complex regulatory environment.

Services Consultancy

Services Commercialisation

PBC BioMed accesses a global network of distributors in the EU, U.S. and Australian markets working closely with each client to match the needs of new product introduction, reimbursement and key opinion leader network to accelerate commercialisation of client innovations.

PBC BioMed can accelerate the commercialisation of client innovations by:

Defining the product positioning Developing a health economic model Generating a robust value proposition incorporating both health economic and

clinical benefits Preparing all related promotional materials and sales tools Generating of pricing model and policy Supporting with reimbursement applications Accessing to global distributor network

Accessing to global KOL network

As part of our commercialisation support PBC BioMed offers a direct to customer sales model, distribution and customer service to hospitals in Ireland & the U.K.

1 Ireland2 UK3 Spain4 Portugal5 France6 Italy7 Germany8 Belguim9 Netherlands10 Nordic

11 Austria12 Switzerland13 Poland14 Turkey15 Czech Republic16 Slovakia17 Greece18 Australia19 New Zealand

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Australia & New Zealand

PBC BioMed Distributor Network in EU & Australia/NZ Regions

Services Contract Manufacturing & Supply Chain Support

Cost effective, compliant and responsive contract manufacturing and Supply Chain services for companies either entering the EU marketplace or those wishing to increase capacity whilst reducing costs.

Contract Manufacturing & Supply Chain SupportPBC BioMed offers assembly, packaging and contract sterilisation and supply chain support of medical devices

ISO Class 8 Cleanroom – 42M2

Facility operates to ISO 13485 and ISO 9001 standards

Medical Device Solutions from Design & Development through to Commericalisation

Process Development & Validation Services

Final Packaging & Labeling Services

Management of Sterilisation Services

Supply Chain Solutions including Customer Service, Storage & Distribution

Strategically located in Ireland, a Major International Medical Device Hub

Excellent Springboard into EU Markets

Ireland is a major international hub for the R&D and production of medical devices, biologics, combination products and pharmaceuticals.

Ireland is home to a closely knit cluster of over 400 Medtech and 120 pharmaceutical companies who are supported by a combination of academic, clinical and government agencies. ¹ ²

To support this manufacturing and R&D activity a wide array of local contract support suppliers has also developed including:Contract ManufacturingPackagingSterilisationPrecision EngineeringExtrusion & MouldingTest Laboratories

4D Western Business Park, Shannon, Co. Clare V14 RW92, Ireland.

+353 (0)61 704740 info@pbcbiomed.ie

www.pbcbiomed.ie

Our Location

Contact Us

References: 1 Irish Medical Device Association; 2 Irish Pharmaceutical Healthcare Association; 3 I.D.A.

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18 of the world’s top 25 medtech companies have manufacturing facilities in Ireland ¹

Over 60% of medtech companies are engaged in R&D ³