Pharmalink ConsultingA Brief Overview

Who we are

• Founded in UK in 1998• Offices in US, Europe and

Asia-Pacific • An extensive network of RA

professionals worldwide- 104 permanent and contract staff as of

Jan 2009- Large, proprietary network of

freelance staff

What we can help with

• Small to large scale projects• Domestic, international and

multinational projects• Short to long term projects• Interim regulatory staffing needs• Assistance at all stages of the

regulatory lifecycle, including:

- Pre and post approval work - CTD and eCTD publishing - Regulatory strategy

Who we work with

• 18 of top 20 healthcare companies• Large pharmaceutical multinationals• Biotechnology & new technologies• Clinical research organizations• Medical device companies• Generic companies• Start-up ventures• Virtual companies

Global Experience

• Europe (EU, Switzerland, Norway, Iceland)

• Middle East and Africa• Asia-Pacific• North America and Canada• Central America and Caribbean

Community• Latin America • Central & Eastern European States • Australia & New Zealand

How we work• Projects served by appropriate

experience- 30+ yrs to 1 yr depending on requirements- Mainstream or specialized experienced- Industry and/or Agency expertise

• Senior Regulatory Managers assisted by junior level staff for data intensive work

How we work

• Additional support from our global network of consultants

• Projects executed on-site or remotely at our offices

• Projects maintained and monitored through secure, dedicated, easy to use, online portal (uploading and tracking/reviewing activity)

Pharmalink ConsultingCase Studies

CLIENT: A major pharmaceutical company based in Europe

PROJECT: A large product compliance project

OBJECTIVE: Review all European-registered licenses and bring into compliance with current manufacturing site practices

SOLUTION: Pharmalink provided a dedicated team of regulatory affairs specialists to work on the project for 3 years

One of the key advantages that Pharmalink was able to bring to the project was the ability to adjust the number of consultants working on the project to fit the client’s needs and hit every deadline whilst always maintaining the level of quality

CASE STUDY 1:

Major regulatory compliance project

PROJECT DETAILS:

• Consultants reviewed registered details against manufacturing site documents, highlighting compliance issues

• Consultants worked with site QA departments in preparing remediation plans for each license

• Over 600 licenses were reviewed and each phase of the project was delivered to the client’s timelines

• Pharmalink’s staff exceeded the client’s expectations on each phase of the defined project, resulting in the client engaging Pharmalink to prepare all of the Variations and submit to all EU agencies in order to bring the product licenses into compliance

CASE STUDY 1:

Major regulatory compliance project

CLIENT: Major pharmaceutical company based in Europe

PROJECT: Review and update of a Module 3 and Quality Overall Summary for a Biosimilar product in preparation for one of the

first European submissions of its type

OBJECTIVE: Document submission. Speed to market was of high

priority to the client

SOLUTION: Pharmalink was able to turn to one of its experienced consultants with a track record specifically with the biotech product in question

Accurate review and submission preparation of the QOS and Module 3

The client could utilize the consultant's advice and make submissions according

to the planned timeline

CASE STUDY 2:

Biosimilar product review

PROJECT DETAILS:

• The consultant reviewed and updated submission documents and provided a pragmatic corrective action listing whilst preparing key parts of the filing

• The consultant added value by preparing a risk analysis alongside the required output, thus ensuring that the client was aware of potential issues once the filing was undertaken

• Work delivered to the client less than a month after the documents were received by Pharmalink

• Pharmalink completed the task by reviewing the project with the client, providing an online facility to feedback on the experience and ensure a satisfactory service, at no cost to the client

• The client submitted the documentation with understanding of the road ahead

CASE STUDY 2:

Biosimilar product review

CASE STUDY 3:

Multinational clinical trial sponsor & Clinical Research Organization

CLIENT: Sponsor and CRO

PROJECT: Provide regulatory support for a clinical trial including new submissions for the trial in multiple markets

OBJECTIVE: Submit the clinical trial in multiple locations in a timely manner to allow trial initiation

SOLUTION: Pharmalink provided consultants with valuable local knowledge to add to the regulatory intelligence of submissions in each market

This project was a testament to the lengths to which the team went to understand the brief and work with the client to achieve their goals

PROJECT DETAILS:

Multinational program - 9 marketsEurope FR, UK, DE, PLEastern Europe Russia, UkraineMiddle East Egypt, IsraelAsia India

• The challenge was to guide a US-based sponsor through the regulatory procedures and processes, different in all markets, whilst work with multiple vendors in areas such as safety reporting, ethics submissions and so forth

• Pharmalink fulfilled the requirements and submissions completed to date have been filed according to the planned schedule

CASE STUDY 3:

Multinational clinical trial sponsor & Clinical Research Organization

CASE STUDY 4:

Multinational clinical trial sponsor & Clinical Research Organization

PROJECT DETAILS:

• Dossiers Collected270

• Dossiers Collated270

• Compliance Assessments Performed270 (10% TPM)

• Remediation Packages Prepared564

• MarketsAT, BE, BU, CH, CY, CZ, DE, DK, EE, EL,ES, FI, FR, HU, IE, IS, IT, LT, LU, LV, MT, NL, NO, PL, PO, RO, SE, SK, UK

CASE STUDY 4:

Product Compliance Project (External)Large Scale Pharmaceutical CompanyPROJECT DETAILS:

CLIENT: Top 10 Pharma Company

PROJECT: Since 2004, Pharmalink Consulting have been successfully performing a large-scale Global Quality Compliance program for a company, covering approximately 1400 Quality Dossiers worldwide

OBJECTIVE: Short term - get product moving around Europe again

Long term - bring all dossiers and licenses up to date providing sustainable compliance

SOLUTION: The team that Pharmalink Consulting assembled has successfully driven all key stages of

the compliance process including:- Quality Dossier collection and

collation into CTD format- CMC Compliance Assessment

- Product Remediation

CASE STUDY 4:

Multinational clinical trial sponsor & Clinical Research Organization

PROJECT DETAILS:

• Dossiers Collected270

• Dossiers Collated270

• Compliance Assessments Performed270 (10% TPM)

• Remediation Packages Prepared564

• MarketsAT, BE, BU, CH, CY, CZ, DE, DK, EE, EL,ES, FI, FR, HU, IE, IS, IT, LT, LU, LV, MT, NL, NO, PL, PO, RO, SE, SK, UK

CASE STUDY 4:

Product Compliance Project (External)Large Scale Pharmaceutical Company

PROJECT DETAILS:

Dossiers Collected270

Dossiers Collated270

Compliance Assessments Performed270 (10% TPM)

Remediation Packages Prepared564

MarketsAT, BE, BU, CH, CY, CZ, DE, DK, EE, EL,ES, FI, FR, HU, IE, IS, IT, LT, LU, LV, MT, NL, NO, PL, PO, RO, SE, SK, UK

CASE STUDY 4:

Multinational clinical trial sponsor & Clinical Research Organization

PROJECT DETAILS:

• Dossiers Collected270

• Dossiers Collated270

• Compliance Assessments Performed270 (10% TPM)

• Remediation Packages Prepared564

• MarketsAT, BE, BU, CH, CY, CZ, DE, DK, EE, EL,ES, FI, FR, HU, IE, IS, IT, LT, LU, LV, MT, NL, NO, PL, PO, RO, SE, SK, UK

CASE STUDY 4:

Product Compliance Project (External)Large Scale Pharmaceutical CompanyPROJECT DETAILS:

• Throughout the compliance project in Europe, the Company was forced to halt product shipment until gap analysis was completed. This put enormous pressure on the team, yet the impact on product shipments remained minimal.

• Various stages of the compliance process were performed remotely from the client, across the Pharmalink offices in North America, Europe and Asia. All objectives and milestones were successfully achieved ahead of target dates.

• The Pharmalink team reached 45 in number at the height of the activity but remained flexible dependent on the workload so were able to adjust accordingly. Pharmalink was able to offer office facilities for the purposes of the project.

• The resulting completion of the European section of the project meant a satisfied client who has continued to employ Pharmalink for regulatory activities across multiple sites in Europe and the United States.

CASE STUDY 4:

Multinational clinical trial sponsor & Clinical Research Organization

CLIENT: Virtual Pharmaceutical Company

PROJECT: A pharmaceutical company required resource to prepare and submit an abridged application for five of their products in a number of Central and Eastern European markets. OBJECTIVE: Collation of required information, and submission to the relevant markets in a timely manner, was very important to the client.

SOLUTION: Pharmalink Consulting was able to assemble the relevant expertise (Non-Clinical, Clinical and Quality) required to undertake a number of activities, within demanding timelines, in order to allow successful execution of the regulatory strategy.

Under the direction of a Pharmalink Project Manager, the appropriate team was assembled that included regulatory executives and regulatory experts. Experts were required to

prepare Non-Clinical and Clinical summaries, and the QOS.

CASE STUDY 5:

Multiple Abridged License ApplicationsVirtual Pharmaceutical Company

CASE STUDY 4:

Multinational clinical trial sponsor & Clinical Research Organization

CASE STUDY 5:

Multiple Abridged License ApplicationVirtual Pharmaceutical Company

PROJECT DETAILS:

•The Project Manager ensured the team assembled all required documentation for the CTD modules 1 to 5.

•The appropriate authorities were contacted, a Reference Member State assigned and the team then submitted the dossier to the EU markets via the decentralized procedure.

•The project team was also responsible for sourcing relevant intelligence, preparing and submitting the generic application to the Russian regulatory authority through a local consultancy team provided by Pharmalink.

•Within two months of receipt of documentation, the Pharmalink team had compiled all necessary modules, ready for submission to the relevant authorities.

•All dossiers were submitted to the relevant authorities within client timelines and within budget.

Pharmalink ConsultingAdditional Information

What else can we offer you?

• Resource backup and alternative, flexible ways of working from regional hubs

• Local knowledge on a global scale

• High Quality Translation Service in 100+ Languages

Fees & Pricing

•You only pay for what we do

•You do not pay retainer fees

•You do not pay daily rates

•Fees based solely on hourly rates and experience

What Clients say"The project was managed very efficiently by their office-based and on-site staff who are always quick to respond to our needs. We continue to use Pharmalink as our preferred source of consultants for long-term and short-term projects."Large Biotech Company

"Many thanks to the Pharmalink project team for doing such a fantastic job. Our MA submissions were delivered very smoothly with impeccable timing."Virtual Pharmaceutical Company

"Each of their staff members have been extremely helpful, efficient, and friendly and have always been willing to go the extra mile to meet our needs."Small Generics Company

"...all projects have been delivered ahead of time or on time. Their experienced and professional approach is mirrored by the resource they supply."Large Generics Manufacturer

1. We have demonstrable capability and experience with large scale multi-product, multi-national regulatory projects on behalf of Top-20 healthcare companies. Our familiarity with such sizeable projects provides our clients with assurance that the desired results can be achieved for any project of any size.

2. Our global regulatory teams are comprised of consultants with a wide range of skills and levels of experience. This allows us to be able to meet client requirements while ensuring that costs are kept to a minimum by using the right level of consultant for the various tasks.

Pharmalink ConsultingOur offering in summary

3 The infrastructure, both in terms of systems and people, that we have established and in which we have invested, underpins our ability to undertake projects of varying scale. We have a purpose-built, centrally-managed IT network for all of our offices worldwide. This will ensure peace of mind as we are able to segregate and secure individual company data while allowing for flexible access.

4. Whilst Pharmalink Consulting is now a multi-national consultancy that is recognized as a global leader in Regulatory Affairs, we remain nimble and flexible to react to our clients’ often urgent requirements.

Pharmalink ConsultingOur offering in summary

Thank you

USA: + 1 800 434 5808

Manhattan, NYShort Hills, NJ Cambridge, MA King of Prussia, PA Durham, NCSan Francisco, CA

UK: + 44 1628 860300

Maidenhead, Berkshire

India: + 91 22 4030 9595

Mumbai