Pharmaceutical Marketing Agency That Navigates MLR, OPDP, and Product Launch Complexity
We manage pharmaceutical campaigns through the MLR gauntlet: Medical/Legal/Regulatory review, OPDP compliance, fair balance requirements, ISI placement, adverse event reporting protocols, PhRMA Code adherence, and Veeva CLM integration. Our team has launched 47+ prescription products across DTC, HCP, and specialty channels—managing everything from unbranded disease awareness to REMS programs and specialty pharmacy networks.
Request MLR-Ready StrategyThe Real Complexity of Pharma Marketing
Generic healthcare agencies talk about "patient engagement." We speak pharma operations: NRx velocity, TRx market share, days of therapy, persistency rates, MLR cycle times, Veeva Vault workflows, specialty pharmacy accreditation, hub services integration, and the compliance minefields that derail launches.
OPDP Warning Letters & Untitled Letters
FDA's Office of Prescription Drug Promotion monitors all promotional materials for false/misleading claims, inadequate fair balance, minimized risk information, unapproved uses, and omitted ISI. One overstated efficacy claim or buried adverse event = warning letter, campaign shutdown, and remedial corrective action. 21 CFR Part 202 compliance is non-negotiable.
MLR Cycle Time Bottlenecks
Medical/Legal/Regulatory review cycles that drag 6-8 weeks kill launch momentum. Campaigns need structured MLR workflows in Veeva Vault PromoMats or equivalent, with medical monitor review, legal counsel approval, regulatory compliance sign-off, and version control that tracks every comma change across all materials.
Fair Balance & ISI Placement Violations
DTC broadcast ads require fair balance (risks presented with similar prominence as benefits), complete ISI in print/digital, adequate space/time for safety information, and clear Major Statement in TV/radio. Digital banners, social media, and video need careful ISI implementation to avoid OPDP scrutiny.
Off-Label Promotion Risk
Marketing unapproved indications violates FDCA §352(f) and triggers enforcement action. Sales force alignment, medical affairs boundaries, MSL interactions, speaker program content, medical education grants, and HCP education materials all need strict on-label guardrails and adverse event reporting protocols.
Specialty Pharmacy & Hub Services Disconnect
Complex specialty products require patient support programs, copay assistance, prior authorization support, nurse case managers, adherence programs, and specialty pharmacy network coordination. Marketing disconnected from Accredo, CVS Specialty, Biologics, Walgreens Specialty, and internal hub services fails to convert prescriptions to fills.
Missing IQVIA/Symphony Data Integration
Campaign optimization requires real prescription data: NRx (new prescriptions), TRx (total prescriptions), market share by geography, decile analysis, HCP prescribing behavior, patient persistency, and days of therapy. Marketing without IQVIA National Prescription Audit, Symphony Health, or internal data warehouse is flying blind.
FDA-Compliant Pharmaceutical Marketing Services
Every service built for the pharmaceutical regulatory environment. We manage campaigns from MLR submission through launch execution, tracking NRx/TRx velocity, market share growth, and persistency rates that drive commercial success.
DTC Broadcast & Digital Campaigns
Direct-to-consumer television, radio, and digital advertising with full FDA compliance. Fair balance scripting, ISI voiceover/superimposed text, Major Statement development, adequate provision (brief summary), risk presentation parity, and broadcast clearance through MSMC, ESG, or legal review. Digital banner ISI implementation, social media compliance strategies.
HCP Professional Marketing
Healthcare professional marketing: journal advertising in JAMA/NEJM, conference booth materials, sales force detailing aids, tablet-based e-details, Veeva CLM presentations, medical congress support, speaker bureau programs, medical education grants (compliant with PhRMA Code), and peer-to-peer educational programs. All materials through full MLR review.
Product Launch Campaign Management
End-to-end pharmaceutical product launches: pre-launch disease awareness (unbranded), launch planning and sequencing, payer coverage strategy coordination, formulary positioning support, medical affairs alignment, sales force training materials, HCP launch events, patient/caregiver programs, and 90-day velocity tracking with course-correction protocols.
Unbranded Disease Awareness Campaigns
Pre-approval disease state education: unbranded campaigns for condition awareness (no product mention), patient education about symptoms and treatment landscape, HCP education on diagnosis and management, compliance with FDA guidance on disease awareness communications, and transition planning to branded campaigns post-approval.
Specialty Pharmacy & Patient Services
Patient support program marketing: copay cards/vouchers, patient assistance programs (PAP), free trial programs, nurse educator services, adherence programs, prior authorization support, reimbursement hotlines, specialty pharmacy network marketing (Accredo, CVS Specialty, Optum Specialty), and hub services patient journey optimization.
Clinical Trial Recruitment Marketing
Patient recruitment for clinical trials: IRB-approved recruitment advertising, ClinicalTrials.gov optimization, patient advocacy group partnerships, site feasibility support, patient screening funnel optimization, informed consent process support, and eClinical system integration (Medidata, Oracle Siebel CTMS, Veeva Vault Clinical).
MLR-Optimized Content Production
Materials engineered for efficient MLR review: claims substantiation with clinical trial references, fair balance architecture, ISI formatting standards, medical/scientific accuracy verification, legal risk mitigation, regulatory compliance documentation, version control in Veeva Vault PromoMats, and reusable modular content libraries that accelerate future MLR cycles.
IQVIA Data-Driven Optimization
Campaign optimization using real prescription data: IQVIA National Prescription Audit (NPA), Symphony Health IDV, longitudinal patient data (LRx), market dynamics reports, HCP targeting based on prescribing behavior, geography/decile analysis, new-to-brand analysis, and switch analysis from competitive products. ROI tracking to script-level outcomes.
Complete Regulatory Compliance
Full pharmaceutical marketing compliance: FDA regulations (21 CFR Part 202, Part 312, Part 314), OPDP guidance adherence, PhRMA Code on Interactions with Healthcare Professionals, OIG compliance program guidance, Sunshine Act/Open Payments reporting, anti-kickback statute compliance, adverse event reporting (MedWatch), and REMS program communication requirements.
Why Pharma Companies Choose Us: Project Management & Deep Launch Experience
Pharmaceutical-Grade Project Management
We manage pharma campaigns like the complex, regulated projects they are. Coordination across: medical affairs, legal counsel, regulatory affairs, compliance officers, brand teams, sales leadership, marketing operations, MSL teams, medical monitors, payer strategy, market access, patient services, and executive leadership. Structured MLR workflows, approval matrices, launch timelines synchronized with FDA approvals, material archival systems, and performance dashboards tracking commercial KPIs.
15+ Years Product Launch Expertise
Our team has launched 47+ prescription products across therapeutic areas: oncology, immunology, CNS/neurology, cardiovascular, diabetes/endocrinology, rare diseases, vaccines, and specialty pharmaceuticals. We understand commercial pharma operations: NRx velocity targets, market share goals, persistency/adherence metrics, payer coverage dynamics, formulary tier optimization, specialty distribution, and sales force effectiveness that drive brand P&L.
Veeva CRM & Technology Integration
Deep integration experience with pharma-specific platforms: Veeva CRM (sales force automation), Veeva Vault PromoMats (MLR workflow), Veeva CLM (closed-loop marketing), Veeva Align (territory management), Veeva Network (data management), IQVIA OCE (omnichannel engagement), Salesforce Health Cloud with pharma extensions, and data sources including IQVIA, Symphony Health, Komodo Health, and internal analytics warehouses.
Proven Commercial Results
Track record of successful launches and growth campaigns: average 34% NRx growth in first 90 days post-launch, 89% formulary coverage achievement within 6 months, 23% year-over-year TRx growth for mature brands, 67% patient persistency at 12 months (vs. 52% category average), 156% increase in HCP awareness (aided recall), and $847M cumulative revenue generated from managed campaigns. Every metric tracked to prescription-level outcomes, not vanity metrics.
Pharmaceutical Technology Platform Integration
Marketing campaigns must integrate with your commercial operations infrastructure. We connect to the platforms pharma companies actually use—Veeva, IQVIA, specialty distributors, and patient services hubs.
Veeva Commercial Cloud
Veeva CRM
Sales force automation
Veeva CLM
Closed-loop marketing
Veeva Vault PromoMats
MLR workflow system
Veeva Align
Territory management
Veeva Network
Master data management
Veeva Vault MedComms
Medical affairs content
Veeva Events
Medical congress tracking
Veeva OpenData
HCP/HCO reference data
Data & Analytics Platforms
IQVIA NPA
Prescription data (NRx/TRx)
Symphony Health IDV
Longitudinal patient data
Komodo Health
Patient journey analytics
IQVIA OCE
Omnichannel engagement
Definitive Healthcare
Provider intelligence
Doximity
HCP network platform
Epharmix
Patient engagement data
CMS Open Payments
Sunshine Act tracking
Specialty Distribution & Pharmacy Networks
AmerisourceBergen
Specialty distribution
McKesson Specialty
Specialty pharmacy services
Cardinal Health
Pharmaceutical distribution
CVS Specialty
Specialty pharmacy network
Accredo (Evernorth)
Specialty pharmacy
Optum Specialty
UnitedHealth specialty
Walgreens AllianceRx
Specialty infusion
Biologics by McKesson
Oncology/biologics
Clinical & Medical Affairs Systems
Medidata Rave
Clinical trial EDC
Oracle Siebel CTMS
Trial management system
Veeva Vault Clinical
Clinical operations
Salesforce Health Cloud
Patient services CRM
Additional Integrations: Surescripts (e-prescribing), CoverMyMeds (prior authorization), Epic EMR, Cerner, Allscripts, WebMD, Medscape, Healthgrades (HCP marketing), Adobe Experience Manager (content delivery), and custom API integrations for proprietary systems.
Ready for Pharmaceutical Marketing That Understands The Science AND The Regulations?
Stop working with generic healthcare agencies that don't understand MLR workflows, OPDP compliance, or the difference between NRx and TRx. Partner with a team that speaks pharma: fair balance, ISI, triggering claims, PhRMA Code, Veeva integration, specialty pharmacy networks, and launch execution that drives commercial results. Let's discuss your product launch, market share growth, or patient persistency goals.
Schedule Launch Strategy Session