Capacities and Capabilities
“We help our customers to go beyond regulatory compliance, to capitalize on greater efficiencies and less complexity and to deliver business value and growth – with confidence.”
Your Partner with Global Reach and Local Presence Marketing Authorization
Ongoing Lifecycle Management & Product Maintenance
DEVELOPMENT CONSULTING & SCIENTIFIC AFFAIRS PHARMACOVIGILANCE REGULATORY AFFAIRS
Who we are - Capacities and Capabilities Global Presence 25 offices in 12 countries with over 650 dedicated experts Expert Knowledge in Development Consulting, Scientific Affairs Pharmacovigilance and Regulatory Affairs with longstanding industry know-how
Broad Experience with all major therapeutic areas and product groups including advanced therapy medicinal products and biopharmaceuticals – ensuring your goals are achieved Passion, Quality, Reliability forward-looking solutions are the foundation of our successful partnerships
We have a proven track record - with more than 25,000 successful projects for over 600 clients worldwide.
Our Services Our teams will take you from the planning stage prior to nonclincial and clinical development, through regulatory submission and approval to product maintenance post-launch. Throughout this process, we will ensure the necessary compliance services needed from the pharmacovigilance perspective.
Development Consulting and Scientific Affairs
Development strategy, gap analysis and due diligences Clinical trial designs Health authority briefing documents
Pharmacovigilance
Regulatory Affairs
ICSR management, including collection, evaluation, processing, distribution and reporting
Procedure management / health authority contact
Signal management
Change control procedures / CMC writing
Scientific advice and health authority meetings
Risk management
CTD clinical & nonclinical documents
Pharmacovigilance system and compliance
PIP / PIP waiver, pediatric study plans
EU-QPPV / local QPPV
Periodic safety reports
Orphan drug designations
Quality system, audit and inspection support
Environmental risk assessment
Safety data exchange agreements
Electronic submission services in all formats
CCDS development and worldwide roll-out Full maintenance service (e.g. variations, renewals) across all regions Initial marketing authorization application Line extensions and referrals GMP, GACP and GDP audit and inspection support
2
Confidence beyond compliance PharmaLex is the leading specialist provider for development consulting, scientific affairs, pharmacovigilance and regulatory affairs - pre- and post-marketing authorization - covering large-scale projects worldwide. Our tailor-made service models range from Customer On-site Support (COS) to the provision of off-site experts, working from one of our offices. Off- and near-shoring possibilities within our organization assure competitive pricing and expedited project delivery. Need more time? We will efficiently reduce your long-term workload.
Customized
Experienced
Scalable
With more than 20 years of industry experience, we can customize a solution that will fit your needs.
We provide dedicated subject matter experts who are passionate about what they do.
Our experts are available when you need them – where you need them – from small scale tactical support to outsourcing of entire product portfolios.
Diversity gives us the ability to tailor a customized plan, which is a key differentiator for our broad client base.
Understanding ensures the perfect fit between expert knowledge and the required flexibility to drive a successful business partnership.
Integrated approach provides expertise and support on all aspects of your project. No detail is too small – no target too large.
Global Presence: Our specialists in 25 offices around the globe are dedicated to guiding you through local regulatory approval processes and providing necessary services at the highest standards.
We are passionate about what we do!
3
Facts and figures Regional distribution of projects
FOUNDED IN
2%
1994
10%
PharmaLex offers unlimited support for your regulatory affairs and pharmacovigilance needs
53%
35%
Global
>25,000
EU only
Germany only
US only
Distribution by customers type (sales)
SUCCESSFUL PROJECTS
4%
>600
31%
CLIENTS 65%
>650
Multinational companies
Mid Cap
Biotech
EMPLOYEES
Contact us to examine your needs, answer your questions and discuss how PharmaLex can best support your project success. For more information, please visit our website at:
www.pharmalex.com
or contact our office
[email protected]
4
Your Partner with Global Reach and Local Presence Marketing Authorization
Ongoing Lifecycle Management & Product Maintenance
DEVELOPMENT CONSULTING & SCIENTIFIC AFFAIRS PHARMACOVIGILANCE REGULATORY AFFAIRS
Who we are - Capacities and Capabilities Global Presence 25 offices in 12 countries with over 650 dedicated experts Expert Knowledge in Development Consulting, Scientific Affairs Pharmacovigilance and Regulatory Affairs with longstanding industry know-how
Broad Experience with all major therapeutic areas and product groups including advanced therapy medicinal products and biopharmaceuticals – ensuring your goals are achieved Passion, Quality, Reliability forward-looking solutions are the foundation of our successful partnerships
We have a proven track record - with more than 25,000 successful projects for over 600 clients worldwide.
Our Services Our teams will take you from the planning stage prior to nonclincial and clinical development, through regulatory submission and approval to product maintenance post-launch. Throughout this process, we will ensure the necessary compliance services needed from the pharmacovigilance perspective.
Development Consulting and Scientific Affairs
Development strategy, gap analysis and due diligences Clinical trial designs Health authority briefing documents
Pharmacovigilance
Regulatory Affairs
ICSR management, including collection, evaluation, processing, distribution and reporting
Procedure management / health authority contact
Signal management
Change control procedures / CMC writing
Scientific advice and health authority meetings
Risk management
CTD clinical & nonclinical documents
Pharmacovigilance system and compliance
PIP / PIP waiver, pediatric study plans
EU-QPPV / local QPPV
Periodic safety reports
Orphan drug designations
Quality system, audit and inspection support
Environmental risk assessment
Safety data exchange agreements
Electronic submission services in all formats
CCDS development and worldwide roll-out Full maintenance service (e.g. variations, renewals) across all regions Initial marketing authorization application Line extensions and referrals GMP, GACP and GDP audit and inspection support
2
Confidence beyond compliance PharmaLex is the leading specialist provider for development consulting, scientific affairs, pharmacovigilance and regulatory affairs - pre- and post-marketing authorization - covering large-scale projects worldwide. Our tailor-made service models range from Customer On-site Support (COS) to the provision of off-site experts, working from one of our offices. Off- and near-shoring possibilities within our organization assure competitive pricing and expedited project delivery. Need more time? We will efficiently reduce your long-term workload.
Customized
Experienced
Scalable
With more than 20 years of industry experience, we can customize a solution that will fit your needs.
We provide dedicated subject matter experts who are passionate about what they do.
Our experts are available when you need them – where you need them – from small scale tactical support to outsourcing of entire product portfolios.
Diversity gives us the ability to tailor a customized plan, which is a key differentiator for our broad client base.
Understanding ensures the perfect fit between expert knowledge and the required flexibility to drive a successful business partnership.
Integrated approach provides expertise and support on all aspects of your project. No detail is too small – no target too large.
Global Presence: Our specialists in 25 offices around the globe are dedicated to guiding you through local regulatory approval processes and providing necessary services at the highest standards.
We are passionate about what we do!
3
Facts and figures Regional distribution of projects
FOUNDED IN
2%
1994
10%
PharmaLex offers unlimited support for your regulatory affairs and pharmacovigilance needs
53%
35%
Global
>25,000
EU only
Germany only
US only
Distribution by customers type (sales)
SUCCESSFUL PROJECTS
4%
>600
31%
CLIENTS 65%
>650
Multinational companies
Mid Cap
Biotech
EMPLOYEES
Contact us to examine your needs, answer your questions and discuss how PharmaLex can best support your project success. For more information, please visit our website at:
www.pharmalex.com
or contact our office
[email protected]
4
