Legal Process Outsourcing for Pharma Industry 
                     Legal 
Process 
Outsourcin
g for 
APerehn LaPOr - mLegala and 
Regulatory Support
Industry 
Overview
Understanding the 
Complexities of Pharma Legal 
and Regulatory Challenges
• Regulatory filings and documentation
• Clinical trial compliance
• Patent protection and IP disputes
• Manufacturing and quality legal 
documentation
Sectors 
Served
Comprehensive legal support 
for pharmaceutical and biotech 
industries in regulatory 
matters
• Pharmaceutical
• Biotech
• Medical Devices
• Regulatory filings and documentation
• Clinical trial compliance
• Patent protection and IP disputes
• Manufacturing and quality legal 
documentation
Key Legal 
Challenges
Navigating complex regulatory 
environments in the 
pharmaceutical sector
• Complex FDA, EMA & ICH compliance 
requirements
• High-volume documentation for drug 
approvals
• Patent litigation and biosimilar disputes
• Clinical trial data and safety reporting 
obligations
Major Legal 
Challenges
Navigating regulatory 
complexities and 
manufacturing risks in the 
pharma sector
• Strict advertising regulations 
hindering effective market 
communication
• Legal risks in supply-chain 
management impacting product quality 
assurance
• Compliance issues affecting 
promotional materials and messaging
Core Legal 
Services
Comprehensive legal support 
tailored for the pharmaceutical 
and biotech industries
• Regulatory Documentation Support: 
INDs, NDAs, BLAs, CMC preparation
• Patent & IP Support: Prior art research, 
claim analysis, patent filing
• Clinical Compliance: Trial agreements, AE 
narratives, audit preparation
Why Choose 
Aeren LPO
Industry Expertise
Aeren LPO provides industry-specific 
knowledge in Pharma and Biotech, 
ensuring compliance with regulations while 
delivering tailored legal solutions that 
enhance operational efficiency.
Contact Us
Partner with Aeren LPO for expert 
legal support and compliance
Email
[email protected]
Website
www.aerenlpo.com