Pharmaceutical and Biotech
Volume XIV of the Sector Coverage Series
For pharma and biotech general counsel, compliance officers, clinical-trial risk teams, and independent investigators retained by manufacturers, CROs, and their insurers.
Professional Reference Material
These playbooks are professional reference material intended for licensed investigators. They are not legal advice. Investigators are responsible for compliance with the laws of their jurisdiction and the specific requirements of their clients and cases.
The TALON Difference
Every playbook in this platform is built against TALON, the proprietary defensive-operations doctrine developed inside The Investigator's Desk over years of federal investigative practice.
Actor-model analysis
Reverse trace
Artifact mapping
evidence econstruction
“Subscribers receive the playbook; the proprietary model that produced it stays inside the platform.”
Pharmaceutical and Biotech, At a Glance
112
Investigative Playbooks
24
Categories
$227
Per Month
within 24-36h
Dispatch
The 112 Pharmaceutical and Biotech Playbooks
The full catalog is listed below by category. Each entry is a standalone playbook covering the case type named.
01. Manufacturing Quality and GMP
GMP violation investigation
Data integrity investigation (ALCOA+)
Batch failure and OOS investigation
Contamination and cross-contamination workup
Warning letter response workup (GMP)
Consent decree and monitorship workup (pharma)
02. Clinical Trial Fraud
Clinical trial investigator fraud
Clinical trial site fraud workup
Subject enrollment fraud workup
Clinical trial data manipulation workup
Informed consent fraud workup
Contract research organization (CRO) fraud workup
03. Drug Counterfeiting
Counterfeit drug investigation
Counterfeit API workup
Online pharmacy counterfeit workup
DSCSA compliance and traceability workup
Counterfeit medical device workup
04. Diversion and Gray Market
Pharmaceutical diversion investigation
Gray market and parallel imports workup (pharma)
Manufacturer employee diversion workup
Wholesaler diversion workup
Reverse distributor fraud workup
05. Pharmacy and Distributor Investigation
Wholesaler compliance investigation
Distributor SOM (suspicious orders) workup
Manufacturer-distributor dispute workup
Specialty distributor fraud workup
PBM contract and rebate audit workup
06. Off-Label Promotion
Off-label promotion investigation
Off-label speaker program workup
Off-label marketing material workup
Off-label sales rep training workup
Medical affairs and IIT workup
07. Kickback and AKS
AKS investigation (pharma)
HCP payment and Sunshine Act workup
Advisory board and consulting workup
PBM kickback and rebate workup
Patient advocacy group workup
08. Speaker Programs and HCP Payments
Speaker program compliance workup
Speaker payment fraud workup
HCP travel and entertainment workup
Ghost speaker and attendee fraud workup
09. Sample Fraud and Diversion
Sample accountability workup
Sample diversion investigation
Sample distribution fraud workup
Sample request fraud workup
10. Copay Assistance and Hub Fraud
Copay assistance program fraud workup
Patient assistance program workup
Hub services fraud workup
Foundation copay workup (AKS)
11. 340B Compliance Investigation
340B eligibility workup
340B duplicate discount workup
340B diversion investigation
340B contract pharmacy workup
12. Pricing and Best Price Fraud
Best price and Medicaid rebate fraud workup
AMP (average manufacturer price) workup
Government pricing workup
Price reporting fraud workup
13. Post-Marketing Safety (PV)
Pharmacovigilance signal investigation
Adverse event reporting fraud workup
Post-marketing commitment workup
Risk Evaluation and Mitigation Strategy (REMS) workup
Signal detection and periodic reporting workup
14. FDA Warning Letter and Enforcement
FDA Form 483 response workup
FDA warning letter response workup
FDA consent decree workup
FDA import alert workup
FDA seizure and injunction workup
FDA inspection preparation and response workup
15. DEA Investigation and Controlled Substance
DEA registrant investigation workup
DEA diversion investigation workup
Controlled substance ordering fraud workup
DEA settlement and MOA workup
CSMP (controlled substance management program) workup
16. FCPA (Pharma)
FCPA investigation workup (pharma)
Third-party diligence workup (pharma)
HCP interaction workup (foreign)
Foreign government official workup
Distribution channel corruption workup (foreign)
17. Product Liability (Pharma)
Pharmaceutical product liability workup
Warning and label defect workup
Design defect workup (pharma)
Manufacturing defect workup (pharma)
MDL and mass tort defense support
Preemption defense workup
18. Recall Investigation (Pharma)
Voluntary recall investigation (pharma)
Mandatory recall workup (pharma)
Recall effectiveness workup (pharma)
Field alert and BPDR workup
19. Trade Secret and IP Theft (Pharma)
Trade secret theft investigation (pharma)
Foreign IP theft workup (pharma)
Patent infringement workup (pharma)
Hatch-Waxman workup
20. Executive Misconduct
CEO/executive expense abuse (pharma)
Executive self-dealing workup
Executive conflict of interest workup
Officer trading and disclosure workup (pharma)
21. Employee Misconduct
Sales rep misconduct workup
Medical science liaison misconduct workup
Manufacturing employee misconduct workup
HR complaint investigation (pharma)
22. Cyber and Data Breach (Pharma)
Pharma data breach investigation
Ransomware incident response (pharma)
BEC and wire fraud investigation (pharma)
Clinical trial data breach workup
23. M&A and Diligence (Pharma)
Pharma M&A due diligence
Compound and license diligence
CRO and CMO acquisition diligence
Reps and warranties investigation (pharma)
24. Emerging Exposure
AI in drug discovery workup
Cell and gene therapy manufacturing workup
Digital therapeutics fraud workup (pharma)
Real-world evidence (RWE) fraud workup
Where Pharmaceutical and Biotech Meets the Rest of the Catalog
Pharmaceutical and biotech investigations regularly cross into adjacent sectors. The volumes listed below carry the framework and playbooks that most often surface alongside a life-sciences matter. Tier 2 subscribers have access to every volume; the cross-references identify where to look first.
Volume II · Banking
HCP payment investigations, rebate and pricing fraud, wire diversion, and financial misconduct involving pharmaceutical and biotech operations.
Volume IX · Manufacturing
GMP-related manufacturing investigations, contamination and cross-contamination, batch failures, quality-system issues, and manufacturing employee misconduct.
Volume XI · Transportation and Logistics
Pharmaceutical diversion, cold-chain and distribution issues, supply-chain investigations, and wholesaler or distributor misconduct.
Volume XV · Insurance
Product-liability claims, recall-related losses, business-interruption claims, and other insurance investigations involving pharmaceutical and biotech companies.
Volume XXIII · Healthcare
Clinical trial fraud, patient assistance and hub program investigations, HCP payment issues, and other healthcare-related matters.
Volume XXVIII · Technology
Clinical trial data breaches, AI in drug discovery, digital therapeutics, and technology-related intellectual property investigations.
What Ships & How
Two Documents Per Case Request
Operational Playbook
The doctrinal chapter: case overview, business and practice framework, investigative blueprint with step cards covering purpose, actions, output, restrictions, and gates, evidence considerations, interview strategy, report considerations, common mistakes, a tabletop exercise with worked answers, closing take, and the case-specific Client Communication Pack of email templates for every touchpoint from proposal through invoicing.
TALON Brief
The actor model for the case typology, the artifact map, and the reverse-trace sequence. This is the doctrine layer that tells the investigator not just what to do, but why those steps in that order, grounded in how actors in that typology actually operate.
Universal Forms
25 universal forms are provided separately as a one-time subscriber download.
Delivery Framework
Case requests → secure email
Dispatch → within 24–36 hours
Maximum → 3 playbooks / rolling 7 days
Monthly reports → scheduled delivery
Quarterly report → scheduled delivery
On-Demand Reports → separate purchase