about pharmalink

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


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.


NORTH AMERICA

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

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


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.

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