Learn more about Pharmalink

An Overview2011

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Pharmalink Profile & CapabilitiesGlobal Regulatory ExperienceProject Experience – Case StudiesAdditional Capabilities Summary

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1. Who we are

Who we are

Founded in UK in 1998Privately heldLeading independent Regulatory Affairs SpecialistOffices in US, Europe, India and Asia‐Pacific155 Staff as of January 2011Large, proprietary network of freelance RA professionals worldwide

Who we work with

18 of top 20 healthcare companies Large pharmaceutical multinationalsConsumer Health organizations and divisionsBiotechnology & new technologyClinical research organizationsMedical device companiesGeneric companiesStart‐up venturesVirtual companies

Consumer Profile

Pharma

Biotech

Medical device

Consumer Health

Veterinary

Generics

Nutraceuticals/Other

2. What we can we help with

What we can help with

Small to large scale projects Domestic, international and multinational projectsShort to long term projectsInterim regulatory staffing needsAssistance at all stages of regulatory lifecycle

What we can help with

Drug Discovery

Non‐clinical

Clinical Development

Pre‐Submission Activity

Filing / Submission

Approval

Product Launch

Post‐Approval

REGULATORYSERVICES

CMC & Manufacturing Compliance

Gap analysis & remediationPreparation ofCTD Module 2 & 3 DMF preparationValidationTPM site identificationContract QPImport documentation and licensingGLP/GMP auditPre‐approval inspections

Regulatory Strategy

Regulatory agency meetingsFiling strategyResponse to agency queriesAdvisory Committee preparationScientific AdviceLifecycle managementInput from Subject Matter Experts

Filing Expertise

IND/IMPDOriginal NDA/MAAANDABLA510K/PMA

Clinical

Preparation ofCTD Module 2 & 5Review of protocols & CSRsCTA preparationReview of IBsIRB/EC documentationOrphan indicationPediatric development plansAmendmentsMedical writingGCP audit

Postmarketing Maintenance

sNDA/variationsAnnual ReportingPostmarketing CommitmentsSafety reporting eg PSUR

Advertising & Promotion/Labeling

USPI/PLR/SPC/CDSUser testingPackaging

Regulatory Operations

CTD/eCTD/dossier preparationSubmission adviceTranslation service

Non‐clinical

Preparation ofCTD Module 2 & 4Review of toxicology & pharmacology studies

RA Solutions that fit your business

RA Solutions that fit your business

A Regulatory Affairs team forall your regulatory needs

Junior consultants to Subject Matter Experts Generalists to specialistsAssistance with projects of any scale and lengthOn‐site or remote working on Domestic, International, and Multinational assignments

How we work

Project are served by appropriate experience– 1 yr to 30+ 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

3. Global Regulatory Experience

Global experience

Our consultants have experience in the following regions:

Europe (EU, Switzerland, Norway, Iceland)Middle East and AfricaNorth America and CanadaCentral America and Caribbean CommunityLatin AmericaCentral & Eastern European statesAustralia & New Zealand

Global Pharmalink OfficesCambridge, MAShort Hills, NJKing of Prussia, PA

Hartford, CTWashington, DCNew York, NYDurham, NC

San Francisco, CA

Maidenhead, UK

Mumbai, India

Singapore

Pharmalink Affiliate Network

LOCAL REGULATORY AFFAIRS WORLDWIDE


Access to local Regulatory Affairsexpertise when and where you need it.The best Regulatory Affairs professionals in every continent.Covering every market from Argentina to Zambia.Leading local consultants who:– understand the culture– will ensure your requirements are met– save you time and money.


AUSTRIA | BELGIUM | CYPRUS | CZECH REPUBLIC | DENMARK | FINLANDFRANCE | GERMANY | GREECE | IRELAND | ITALY | NETHERLANDS

PORTUGAL | SPAIN | SWEDEN | SWITZERLAND | TURKEY | UK (GLOBAL HQ)

EUROPE


ME‐NA


AFRICA

ANGOLA | BOTSWANA | DEMOCRATIC REPUBLIC OF CONGO | LESOTHOMADAGASCAR | MALAWI | MAURITIUS | MOZAMBIQUE

NAMIBIA | SOUTH AFRICA | SWAZILAND | TANZANIA | ZAMBIA | ZIMBABWE


EASTERNEUROPE

ALBANIA | AZERBAIJAN | BOSNIA & HERZEGOVINA | BULGARIA | CROATIAESTONIA | GEORGIA | HUNGARY | KAZAKHSTAN

KOSOVO | MACEDONIA | MOLDOVA | MONTENEGRO | POLAND | ROMANIARUSSIA | SERBIA | SLOVAKIA | SLOVENIA | UKRAINE | UZBEKISTAN


ASIA PAC

AUSTRALIA | CHINA | HONG KONG | INDIAJAPAN | MALAYSIA | NEW ZEALAND | PHILIPPINES | SINGAPORE

SOUTH KOREA | THAILAND


NORTH AMERICA

CANADAUNITED STATES: NJ (US HQ) | MA | CT | NY | PA | NC | CA | DC


ARGENTINA | ARUBA | BELIZE | BRAZIL | CHILE | COLOMBIA | COSTA RICADOMINICAN REPUBLIC | ECUADOR | EL SALVADOR | GUATEMALA

HONDURAS | JAMAICA | MEXICO | NICARAGUAPANAMA | PARAGUAY | PERU | PUERTO RICO | TRINIDAD | VENEZUELA

4. Case Studies

Case Study 1

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.

CLIENTPROJECTOBJECTIVE

SOLUTION

A major pharmaceutical company based in Europe.A large compliance project.Review all European‐registered licenses and bring into compliance with current manufacturing site practices.Pharmalink provided a dedicated team of regulatory affairs specialists to work on the project for 3 years.

Major regulatory compliance project

Case Study 1

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 EUagencies in order to bring the product licenses intocompliance.

Project Details

Case Study 2

CLIENTPROJECT

OBJECTIVE

SOLUTION

A major pharmaceutical company based in Europe.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.Document submission.Speed to market was of high priority to the client.Pharmalink was able to turn to one of its experienced consultants with a track record specifically with the biotech product in question.

Biosimilar Product Review

Case Study 2

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 understandingof the road ahead.

Project Details

Case Study 3

This project was a testament to the lengths to which the teamwent to understand the brief and work with the clientto achieve their goals.

CLIENTPROJECT

OBJECTIVE

SOLUTION

Sponsor and CRO.Provide regulatory support for a clinical trial including new submissions for the trial in multiple markets.

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

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

Multinational clinical trial sponsor & Clinical Research Organization

Case Study 3

Project DetailsMultinational program ‐ 9 markets– Europe FR, UK, DE, PL– Eastern Europe Russia, Ukraine– Middle East Egypt, Israel– Asia 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 4

CLIENTPROJECT

OBJECTIVE

SOLUTION

Top 10 Pharma Company.Since 2004, Pharmalink Consulting have been successfully performing a large‐scale Global Quality Compliance program for a company, covering approximately 1400 Quality Dossiers worldwide.Short term – get product moving around Europe again.Long term – bring all dossiers and licenses up to date providing sustainable compliance.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

Global Product Compliance ProjectLarge Pharmaceutical Company

Case Study 4

Project DetailsDossiers Collected270Dossiers Collated270Compliance Assessments Performed270 (10% TPM)Remediation Packages Prepared564MarketsAT, BE, BU, CH, CY, CZ, DE, DK, EE, EL,ES, FI, FR, HU, IE, IS, IT, LT, LV, MT, NL, NO, PL, PO, RO, SE, SK, UK

Case Study 4

Project DetailsThroughout the compliance project in Europe, the Company was forced to halt product shipment until gap analysis was completed. This putenormous 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.

5. Additional Capabilities

Permanent Staffing

Pharmalink Consulting, the regulatory affairs specialists since 1998, introduces a unique regulatory recruitment solution

Pharmalink has unrivalled access to permanent regulatory affairs candidates throughout the industry.

All of our candidates have been interviewed by Senior Regulatory Affairs professionals familiar with client needs.

We can offer optional interim staffing by one of our regulatory affairs consultants while we identify

your ideal permanent employee.

Permanent Staffing

The Pharmalink Permanent Solution 6 Step Plan

You identify a permanent recruitment need

Contact Pharmalink, where an experienced regulatory affairs professionalwill discussyour requirementand take a detailed brief

Pharmalink can provide an experienced consultant to act as an interim memberof staff whilewe identify your ideal permanent employee

We research our extensive portfolio of regulatory affairs professionalswho have previously been screened and vetted

Pharmalinkprovides a selection of chosen candidates for you to meet and consider

Following selection, your new memberof staff commences role

STEP 1 STEP 2 STEP 3[optional]

STEP 4 STEP 5 STEP 6

What else can we offer you?

Resource backup and alternative, flexible ways of working from regional hubsLocal knowledge on a global scaleHigh Quality Translation Service in 100+ LanguagesA company accredited with QMS ISO 9001A company accredited with IIP statusRecently completed a $2.4 million investment programElectronic publishing ‐ eSubmissions

6. Summary

Our offering in summary

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.


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.

USA: + 1 800 434 5808SHORT HILLS, NJ | CAMBRIDGE, MA | HARTFORD, CT | MANHATTAN, NY | KING OF PRUSSIA, PA

DURHAM, NC | SAN FRANCISCO, CA | WASHINGTON, DC

UK: + 44 1628 860300MAIDENHEAD, BERKSHIRE

INDIA: + 91 22 4030 9595MUMBAI

SINGAPORE: + 65 6408 0515

Thank you

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