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An Overview
Pharmalink
Profile & Capabilities
Global Regulatory Experience
Project Experience – Case Studies
Additional Capabilities
Summary
Your presentation today
1. Who we are
Who we are
Founded in UK in 1998
Privately held
Leading independent Regulatory Affairs
Specialist
Offices in Europe, US, India and Asia-Pacific
155 Staff as of May 2011
Large, proprietary network of freelance RA
professionals worldwide
Revenues in excess of $25 million in 2010
Who we work with
18 of top 20 healthcare companies Large pharmaceutical multinationals Consumer Health organizations and divisions Biotechnology & new technology Clinical research organizations Medical device companies Generic companies Start-up ventures Virtual companies
Consumer Profile
Pharma
Biotech
Medical device
Consumer Health
Veterinary
Generics
Nutraceuticals/Other
2. What we can help with
What we can help with
Projects of any scale or duration Domestic, international and multinational
projects Interim regulatory staffing needs Assistance at all stages of regulatory lifecycle
What we can help with
Non-clinical
Clinical Development
Pre-Submission Activity
Filing / Submission
Approval
Product Launch
Post-Approval
REGULATORY SERVICES CMC & Manufacturing Compliance
Gap analysis & remediation
Preparation of
CTD Module 2 & 3
DMF preparation
Validation
TPM site identification
Contract QP
Import documentation and licensing
GLP/GMP audit
Pre-approval inspections
Regulatory Strategy
Regulatory agency meetings
Filing strategy
Response to agency queries
Advisory Committee preparation
Scientific Advice
Lifecycle management
Input from Subject Matter Experts
Filing Expertise IND/IMPD
Original NDA/MAA
ANDA
BLA
510K/PMA
Clinical
Preparation of
CTD Module 2 & 5
Review of protocols & CSRs
CTA preparation
Review of IBs
IRB/EC documentation
Orphan indication
Pediatric development plans
Amendments
Medical writing
GCP audit
Postmarketing Maintenance sNDA/variations
Annual Reporting
Postmarketing Commitments
Safety reporting eg PSUR
Advertising & Promotion/Labeling
USPI/PLR/SPC/CDS
User testing
Packaging
Regulatory Operations
CTD/eCTD/dossier preparation
Submission advice
Translation service
Non-clinical
Preparation of
CTD Module 2 & 4
Review of toxicology & pharmacology studies
RA Solutions that fit your business
RA Solutions that fit your business
A Regulatory Affairs team for all your regulatory needs
Junior consultants to Subject Matter Experts Generalists to specialists Assistance with projects of any scale and
length On-site or remote working on Domestic,
International, and Multinational assignments
How we work
Project are 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
3. Global Regulatory Experience
Global experience
Our consultants have experience in the following regions: Europe (EU, Switzerland, Norway, Iceland) Middle East and Africa North America and Canada Central America and Caribbean Community Latin America Central & Eastern European states Australia & New Zealand Asia-Pacific
Global Pharmalink Offices
Cambridge, MA Short Hills, NJ King of Prussia, PA
Hartford, CT Washington, DC New York, NY Durham, NC
San Francisco, CA
Maidenhead, UK
Mumbai, India
Singapore
Pharmalink Affiliate Network
Loca l Regulatory Affa i rs Wor ldwide
Pharmalink Affiliate Network
Access to local Regulatory Affairs expertise 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.
Pharmalink Affiliate Network
AUSTRIA | BELGIUM | CYPRUS | CZECH REPUBLIC | DENMARK | FINLAND FRANCE | GERMANY | GREECE | IRELAND | ITALY | NETHERLANDS
PORTUGAL | SPAIN | SWEDEN | SWITZERLAND | TURKEY | UK (GLOBAL HQ)
EUROPE
Pharmalink Affiliate Network
ME-NA
ALGERIA | BAHRAIN | EGYPT | ISRAEL | JORDAN | KUWAIT | LEBANON MOROCCO | OMAN | QATAR | SAUDI ARABIA | TUNISIA | UAE
Pharmalink Affiliate Network
AFRICA
ANGOLA | BOTSWANA | DEMOCRATIC REPUBLIC OF CONGO | LESOTHO MADAGASCAR | MALAWI | MAURITIUS | MOZAMBIQUE
NAMIBIA | SOUTH AFRICA | SWAZILAND | TANZANIA | ZAMBIA | ZIMBABWE
Pharmalink Affiliate Network
EASTERN EUROPE
ALBANIA | AZERBAIJAN | BOSNIA & HERZEGOVINA | BULGARIA | CROATIA ESTONIA | GEORGIA | HUNGARY | KAZAKHSTAN
KOSOVO | MACEDONIA | MOLDOVA | MONTENEGRO | POLAND | ROMANIA RUSSIA | SERBIA | SLOVAKIA | SLOVENIA | UKRAINE | UZBEKISTAN
Pharmalink Affiliate Network
ASIA PAC
AUSTRALIA | CHINA | HONG KONG | INDIA JAPAN | MALAYSIA | NEW ZEALAND | PHILIPPINES | SINGAPORE
SOUTH KOREA | THAILAND
Pharmalink Affiliate Network
NORTH AMERICA
CANADA UNITED STATES: NJ (US HQ) | MA | CT | NY | PA | NC | CA | DC
Pharmalink Affiliate Network
ARGENTINA | ARUBA | BELIZE | BRAZIL | CHILE | COLOMBIA | COSTA RICA DOMINICAN REPUBLIC | ECUADOR | EL SALVADOR | GUATEMALA
HONDURAS | JAMAICA | MEXICO | NICARAGUA PANAMA | PARAGUAY | PERU | PUERTO RICO | TRINIDAD | VENEZUELA
LATIN AMERICA
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.
CLIENT
PROJECT
OBJECTIVE
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 EU agencies in order to
bring the product licenses into compliance.
Project Details
Case Study 2
CLIENT
PROJECT
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 Project
Case Study 2
Project Details
Dossiers Collected – 270
Dossiers Collated – 270
Compliance Assessments Performed - 270 (10% TPM)
Remediation Packages Prepared – 564
Markets -
AT, 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 2
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, 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 3
CLIENT Top 10 Pharma Company.
PROJECT Since 2004, Pharmalink have been involved with a large scale
global integration project.
OBJECTIVE Short term – Assemble and assess documentation.
Long term – complete ownership changes and related regulatory
activity to bring dossiers and licenses in line with parent company.
The team that Pharmalink Consulting assembled successfully enabled
license transfer and documentation incorporation all key stages of
the compliance process including:
- data gathering - reviewed existing documentation, job descriptions,
SOPs, job aids, interviewed staff
- Mapped process(es) - deployment,
interactions, comparison against best practice
- Recommendations presented to sponsor –
Appropriate to the organization concerned
Organization Acquisition Project
Case Study 3
Project Details
Project sponsorship – It was important to get high level buy-in and support and
confirm mutual understanding of deliverables and objectives. At an early stage
effective communication and ‘marketing’ of activities was developed to overcome
potential issues.
Environmental issues – Given the cultural differences between sites, areas of
organisation Pharmalink worked with the project sponsor to identify the potential
roadblocks to a successful outcome – Often M&A ‘fallout’ can present barriers to
success.
The Pharmalink team adjusted the resources at various stages to deal with short
term increases in workload, but remained flexible. Pharmalink was able to offer
office facilities for the purposes of the project.
The resulting completion of the integration meant that the organization was able to
operate a ‘business as usual’ model, despite the uncertainty and disruption
associated with many mergers and acquisitions. A satisfied client who has
continued to employ Pharmalink for regulatory activities across multiple sites in
Europe and the United States.
Case Study 4
CLIENT
PROJECT
OBJECTIVE
SOLUTION
Top 10 Pharma Company.
Since 2000, Pharmalink Consulting have been engaged in an operational role in a license integration, site rationalization, and a quality compliance project.
Short term – Assist client company meeting legal and commercial obligations and targets as a result of merger. Long term – complete source transfers and related regulatory activity to enable seamless supply chain.
The team that Pharmalink Consulting assembled successfully enabled license transfer and documentation incorporation all key stages of the compliance process including:
– site transfers including internal and TPM sites, covering markets worldwide. – Performed quality & compliance reviews.
Merger & Quality Compliance Project Large Pharmaceutical Company
Case Study 4
Project Details
Pharmalink was the operational regulatory partner in the UK and US for site
rationalisation and product quality compliance resulting from a high profile
merger between two large pharmaceutical companies. The key performance
indicator was the need for cost saving and manufacturing rationalisation –
central to these activities.
Pharmalink was tasked with identifying requirements, timing, and delivering site
transfers for worldwide markets. In parallel with this activity the team completed
a quality compliance review on all products that enabled a full regulatory strategy
to be available when sourcing decisions had to be made.
The Pharmalink core team of 25 was adjusted as requirements varied and
reached 60 at its peak. Following the merger activity in 2005 Pharmalink has
maintained smaller team to continue routine source transfers.
The volume and complexity of the project was managed successfully and key
merger targets achieved. The client was satisfied and continues to employ
Pharmalink for a variety of regulatory activities across its sites.
5. Additional Capabilities
What else can we offer you?
High Quality Translation Service in 100+ Languages
Operations and publishing - eSubmissions
6. Summary
What else can we offer you?
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.
What else can we offer you?
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.
What else can we offer you?
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.
What else can we offer you?
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.
UK: + 44 1628 860300 MAIDENHEAD, BERKSHIRE
USA: + 1 800 434 5808 SHORT HILLS, NJ | CAMBRIDGE, MA | HARTFORD, CT | MANHATTAN, NY | KING OF PRUSSIA, PA
DURHAM, NC | SAN FRANCISCO, CA | WASHINGTON, DC
INDIA: + 91 22 4030 9595 MUMBAI
SINGAPORE: + 65 6408 0515
Thank you