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About US:

PharmaLex utilizes the strength and breadth of it multidisciplinary team, as well as its extensive global network, to help clients navigate the regulatory landscape. We specialize in development consulting & scientific affairs, regulatory affairs and pharmacovigilance, offering customized and individually adapted solutions. We manage large-scale outsourcing projects as well as providing strategic project support for specialist indications that require expert knowledge. We collaborate with you to advocate for your company, your ideas, and your products. 

Web Site: www.pharmalex.com

PharmaLex GmbH 
Harrlachweg 6 
68163 Mannheim 
Phone: +49 621 18 15 38 0 
Email: contact@pharmalex.com 


Eva Keck  
Director Marketing 
Social Media Links:  
LinkedIn: https://www.linkedin.com/company/pharmalex-gmbh  
Xing: https://www.xing.com/companies/pharmalexgmbh  
Twitter: https://twitter.com/PharmaLexUS 

Geographic Areas: Worldwide  
Business Type: Service Provider                
Products: Medicinal products
New active substances
Biological products and chemical entities
Advanced therapies
Orphan medicinal products
Herbals & Homeopathics
Borderline products
Medical Devices 
Veterinary Medicines 
Professional Responsibility: Development Consulting & Scientific Affairs
• Development strategy and gap analysis
• Clinical trial designs
• Health authority briefing documents
• Scientific advice and health authority meetings
• Due diligences
• CTD clinical & nonclinical documents
• PIP / PIP waiver, pediatric study plans

• Environmental risk assessment

• Risk management
• Signal management
• Periodic safety reports
• Pharmacovigilance system and compliance
• EU-QPPV / local QPPV
• Quality system, audit and inspection support
• Safety data exchange agreements
• ICSR management, including collection, evaluation, processing, distribution and reporting 

Professional Responsibility (Regulatory Process): Regulatory Affairs
• Procedure management / health authority contact 
• Electronic submission services in all formats
• Change control procedures / CMC writing
• CCDS development and worldwide roll-out
• Full maintenance service
• Initial marketing authorization application, 
• Line extensions and referrals 
Other Professional Responsibility: Statistical services – clinical and nonclinical