Pharmalink Consulting
A Brief Overview
Who we are

    Founded in UK in 1998
•
    Offices in US, Europe and Asia-Pacific
•
    An extensive network of RA profes...
What we can help with
    Small to large scale projects
•
    Domestic, international and multinational
•
    projects
   ...
Who we work with
•   18 of top 20 healthcare companies
•   Large pharmaceutical multinationals
•   Biotechnology & new tec...
Global Experience

•   Europe (EU, Switzerland, Norway, Iceland)
•   Middle East and Africa
•   Asia-Pacific
•   North Ame...
How we work

    Projects served by appropriate experience
•
     - 30+ yrs to 1 yr depending on requirements
     - Mains...
How we work

    Additional support from our global network of
•
    consultants
    Projects executed on-site or remotely...
Pharmalink Consulting
Case Studies
CASE STUDY 1:
           Major regulatory compliance project


CLIENT:          A major pharmaceutical company based in Eu...
CASE STUDY 1:
            Major regulatory compliance project

PROJECT DETAILS:

•   Consultants reviewed registered detai...
CASE STUDY 2:

           Biosimilar product review

CLIENT:          Major pharmaceutical company based in Europe

PROJEC...
CASE STUDY 2:

            Biosimilar product review
PROJECT DETAILS:

•   The consultant reviewed and updated submission ...
CASE STUDY 3:
            Multinational clinical trial sponsor &
            Clinical Research Organization

CLIENT:      ...
CASE STUDY 3:
            Multinational clinical trial sponsor &
            Clinical Research Organization

PROJECT DETAI...
CASE STUDY 4:
                CASE STUDY 4:

                Multinational clinicalProject (External)
                 Pro...
CASE STUDY 4:4:
              CASE STUDY
              Product Compliance Project (External)
             Multinational cl...
CASE STUDY 4:
                  CASE STUDY 4:
                  Product Compliance Project (External)
                  Mu...
CASE STUDY 4:5:
              CASE STUDY

             Multinational clinical trial Applications
              Multiple Ab...
CASE STUDY 5:
                  CASE STUDY 4:
                  Multiple Abridged License Application
                  Mu...
Pharmalink Consulting
Additional Information
What else can we offer you?

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

    L...
Fees & Pricing


ou only pay for what we do


ou do not pay retainer fees


ou do not pay daily rates


ees based solely o...
What Clients say
quot;The project was managed very efficiently by their office-based and on-site staff who are
always quic...
Pharmalink Consulting
           Our offering in summary

1.   We have demonstrable capability and experience with large s...
Pharmalink Consulting
          Our offering in summary

3    The infrastructure, both in terms of systems and people, tha...
Thank you

USA: + 1 800 434 5808      UK:   + 44 1628 860300
Manhattan, NY              Maidenhead, Berkshire
Short Hills,...
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Learn More About Pharmalink

  1. 1. Pharmalink Consulting A Brief Overview
  2. 2. 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
  3. 3. 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
  4. 4. 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
  5. 5. 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
  6. 6. 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
  7. 7. 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)
  8. 8. Pharmalink Consulting Case Studies
  9. 9. CASE STUDY 1: Major regulatory compliance project 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
  10. 10. 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
  11. 11. CASE STUDY 2: Biosimilar product review 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
  12. 12. 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
  13. 13. 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
  14. 14. CASE STUDY 3: Multinational clinical trial sponsor & Clinical Research Organization PROJECT DETAILS: Multinational 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
  15. 15. CASE STUDY 4: CASE STUDY 4: Multinational clinicalProject (External) Product Compliance trial sponsor & Large Scale Pharmaceutical Company Clinical Research Organization PROJECT DETAILS: PROJECT DETAILS: CLIENT: Top 10 Pharma Company Dossiers Collected PROJECT: Since 2004, Pharmalink Consulting have been successfully • performing a large-scale Global Quality Compliance program 270 for a company, covering approximately 1400 Quality Dossiers Dossiers Collated • worldwide 270 OBJECTIVE: Short term - get product moving around Europe again Compliance Assessments Performed • Long term - bring all dossiers and licenses up to date 270 (10% TPM)providing sustainable compliance Remediation Packages Prepared • SOLUTION: The team that Pharmalink Consulting assembled has 564 successfully driven all key stages of the compliance process including: Markets • - Quality Dossier collection and collation into CTD format AT, 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, CMC Compliance Assessment - SE, SK, UK - Product Remediation
  16. 16. CASE STUDY 4:4: CASE STUDY Product Compliance Project (External) Multinational clinical trial sponsor & Large Scale Pharmaceutical Company Clinical Research Organization PROJECT DETAILS: PROJECT DETAILS: Dossiers Collected •270 Dossiers Collected 270 Dossiers Collated Dossiers Collated •270 270 Compliance Assessments Performed Compliance Assessments Performed • 270 (10% TPM) 270 (10% TPM) •Remediation Packages Prepared Remediation Packages Prepared 564 564 •Markets Markets AT, BE, BU, CH, CY, CZ, DE, DK, EE, EL,ES, FI,FI, FR, HU,IS, IT, LT, LU, LV, MT, AT, BE, BU, CH, CY, CZ, DE, DK, EE, EL,ES, FR, HU, IE, IE, IS, IT, LT, LU, LV,NL, NO, PL, PO,PL, PO, RO, UK SK, UK MT, NL, NO, RO, SE, SK, SE,
  17. 17. CASE STUDY 4: CASE STUDY 4: Product Compliance Project (External) Multinational clinical trial sponsor & Large Scale Pharmaceutical Company Clinical Research Organization PROJECT DETAILS: PROJECT 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, Dossiers Collected • yet the impact on product shipments remained minimal. 270 Dossiers Collated • • Various stages of the compliance process were performed remotely from the client, 270 across the Pharmalink offices in North America, Europe and Asia. All objectives and Compliance Assessments Performed milestones were successfully achieved ahead of target dates. • 270 (10% TPM) • The Pharmalink team reachedPrepared Remediation Packages 45 in number at the height of the activity but remained • flexible dependent on the workload so were able to adjust accordingly. Pharmalink 564 was able to offer office facilities for the purposes of the project. Markets • The resulting BU, CH, CY, CZ, DE, DK, EE, EL,ES, FI, FR, HU, meant aIT, LT, LU, LV, MT, AT, BE, completion of the European section of the project IE, IS, satisfied client • who has continuedPO,employ Pharmalink for regulatory activities across multiple sites NL, NO, PL, to RO, SE, SK, UK in Europe and the United States.
  18. 18. CASE STUDY 4:5: CASE STUDY Multinational clinical trial Applications Multiple Abridged License sponsor & ClinicalPharmaceutical Company Virtual 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.
  19. 19. CASE STUDY 5: CASE STUDY 4: Multiple Abridged License Application Multinational clinical trial sponsor & Virtual Pharmaceutical Company Clinical Research Organization 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.
  20. 20. Pharmalink Consulting Additional Information
  21. 21. 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
  22. 22. Fees & Pricing ou only pay for what we do ou do not pay retainer fees ou do not pay daily rates ees based solely on hourly rates and
  23. 23. What Clients say quot;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.quot; Large Biotech Company quot;Many thanks to the Pharmalink project team for doing such a fantastic job. Our MA submissions were delivered very smoothly with impeccable timing.quot; Virtual Pharmaceutical Company quot;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.quot; Small Generics Company quot;...all projects have been delivered ahead of time or on time. Their experienced and professional approach is mirrored by the resource they supply.quot; Large Generics Manufacturer
  24. 24. Pharmalink Consulting 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. 3. 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.
  25. 25. Pharmalink Consulting Our 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.
  26. 26. Thank you USA: + 1 800 434 5808 UK: + 44 1628 860300 Manhattan, NY Maidenhead, Berkshire Short Hills, NJ Cambridge, MA King of Prussia, PA India: + 91 22 4030 9595 Durham, NC Mumbai San Francisco, CA

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