Your Partner with Global Reach

and Local Presence

Reduce costsby

innovative solutions

Offering end-to-end solutions

Outsourcing of product maintenance

activities

Early research & development Pre-approval

PharmaLex is one of the largest providers for Development Consulting, Regulatory Affairs,

Quality Management & Compliance and Pharmacovigilance worldwide. Our global teams of

experts can take you through early strategic planning activities and nonclinical requirements to

clinical development, through regulatory submission processes and finally guide you to market

approval and product maintenance post-launch activities. We strive to deliver exceptional

results — going above and beyond the standard to deliver tailor-made solutions. We aim to

exceed your expectations and live by our values - flexibility, efficiency, passion & dedication.

Regulatory and scientific consultancy servicesIntegrated product development and project managementRegulatory strategy (incl. health agency interactions), gap analysis and due diligenceScientific, regulatory and medical writingDevelopment CMC, consulting and manufacturing strategyStatistical services across nonclinical and clinical developmentHealth economics / market access / pricing / strategic adviceLabeling servicesMedical affairs & marketing strategy

Initial marketing authorizationapplications, line extensions and referralsin > 80 countries worldwideFull portfolio maintenance service (e.g. variations, renewals) across all regionsGlobal roll-out strategy for new submissions including due diligence activitiesConsultancy and regulatory operations during M&A activitiesChange control procedures/ CMC writing for chemicals and biologicalsElectronic submission services in all formatsCCDS development & worldwide roll-outProcedure management and health agency contacts

Confidence beyond compliance

Development Consulting Regulatory Affairs

New drug application Post-approval

PharmaLex supports drug development and maintenance activities, covering all health

agency obligations with a strong global footprint!

ICSR management, including collection,evaluation, processing, distribution and reporting (incl. validated safety database)Signal managementRisk managementPeriodic safety reportsPharmacovigilance system and complianceEU-QPPV / local QPPVQuality system, audit and inspection supportSafety data exchange agreements

Pharmacoepidemiology

Develop phase appropriate quality systemGap analysis, remediation and implementationPre-approval inspection readiness (Mock PAI audit)Warning letter and consent decree remediationExternal and internal auditsRoutine compliance support (Document control, CAPA, batch release)EDMS and CSV (21 CFR part 11 compliance)Microbiology and analytical quality control support

PharmacovigilanceQuality Management & Compliance

Reach us at contact@pharmalex.com or visit our website at www.pharmalex.com

Customized Experienced Scalable

PharmaLex experts average 20 years of experience and can customize a solution that will fit your organization‘s needs.

We provide dedicated subject matter experts who are passionate about what they do.

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.

Facts and figures

{SINCE

1994PharmaLex offers unlimited support

>30,000SUCCESSFUL PROJECTS

>600CLIENTS

Regional distribution of projects

39%

15%

46%

Distribution by customer type

29% 60%

11%

Global EU only US only

Multinational companies

Mid-cap Biotech

Our experts are available when you need them - where you need them - from small scale tactical support to outsourcing of entire product portfolios.