Pharmalex

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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
Address:

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

Contact:

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
Generics
Biosimilars
Orphan medicinal products
Herbals & Homeopathics
Borderline products
Cosmetics 
Medical Devices 
Veterinary Medicines 
Food
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

Pharmacovigilance
• 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