Pharmaceutical Industry
Legal Support for Pharmaceutical Companies That Can't Afford Operational Gaps
Pharmaceutical legal work sits at the intersection of science, regulation, and litigation, and the operational demands are unlike most industries. Clinical trial agreements carry FDA compliance obligations. A single mass tort MDL can generate document populations that number in the millions and run for years. A missed obligation in a CMO contract is a GMP audit finding.
Aeren LPO works inside this complexity, not around it.
Managed Document Review
Adverse event reports, internal safety communications, labeling records, regulatory correspondence- these documents require reviewers who can distinguish what is legally significant from what is scientifically routine.
We deploy TAR 2.0 with Continuous Active Learning alongside attorney-supervised review teams, building protocols around the specific litigation type rather than a generic responsiveness framework. Every production is defensible. Every privilege log is built to hold up.
Where we work:
- Class action and MDL litigation
- PTAB proceedings
- Product liability and failure-to-warn defense
- Government investigations and DOJ enforcement response
- PII/PHI identification under HIPAA
Contract Lifecycle Management
A pharmaceutical company's contract portfolio doesn't just carry commercial risk, it carries regulatory accountability. Agreements with research partners (CROs), manufacturers (CMOs), and quality teams all come with rules set by regulators like the FDA, GMP, GCP, and HIPAA. If those rules aren’t tracked properly, the fallout isn’t only legal — it can disrupt day-to-day operations too.
We take care of the entire contract process: keeping track of obligations, sending renewal reminders, managing versions, and monitoring compliance — all aligned with the regulations pharma companies actually work under.
Contract types we handle:
- Clinical trial agreements (CTAs)
- Manufacturing and supply contracts (CMO/CDMO)
- Quality and vendor agreements
- Distribution and GPO contracts
