For emerging biopharma teams, the 12–24 months before launch involve multiple interconnected priorities — and a gap in one area can create risk somewhere else.
The Pre-Launch Readiness Assessment gives your team a structured way to evaluate where you stand, where gaps exist, and what to prioritize before launch day.
The assessment helps your team evaluate what is in place, what remains in progress, and where gaps exist across six interconnected areas of commercialization:
For each question, answer Yes, In Progress, or No. Your overall score provides a starting point — but where gaps cluster and how they connect across workstreams is where the real picture emerges.
How to use this:
Work through each question and answer honestly: Yes, No, or In Progress.
Your answers will be converted into a readiness percentage, with 100% representing full readiness. In Progress and No responses reduce your score based on the level of remaining work. The lowest-scoring questions, and the sections where gaps cluster, usual tells you where risk is concentrating, where timing is starting to matter, and where early action saves disproportionate pain later.
Your 3PL selection isn’t just an operations decision. It shapes your DSCSA serialization design, your ability to support specialty channels, and, through how the product gets enrolled in federal programs, your downstream Medicaid and government pricing obligations. Licensing sequencing is the first domino, not the last.
Where EPG fits: Two Labs leads state licensing strategy and 3PL selection and management day-to-day, along with DSCSA implementation guidance and support. EPG Strategic Consulting provides the integrated launch plan that sequences licensing against approval timing, hiring, and channel decisions. Riparian surfaces the government pricing and revenue management implications of where, and how, you launch.
A late REMS signal from FDA doesn’t just reshape patient services. It changes channel design, hub workflows, prescriber onboarding, and the commercial launch timeline. DSCSA master data ties directly back to compendia submissions and electronic prescribing platforms (EHRx)14 visibility. DPT reporting is tied to both product launches and pricing decisions. Pricing milestones often drive compliance activities and reporting timelines in applicable jurisdictions. Similarly, the policies, processes, and systems established for DPT and Sunshine during pre-launch help ensure organizations are prepared to meet reporting obligations once they become applicable, rather than scrambling to build processes after commercialization.
Where EPG fits: Two Labs runs DSCSA serialization, DPT, and Sunshine/Open Payments compliance day-to-day. Shepherd Safety Services leads REMS strategy, risk assessment, and program management end-to-end. Riparian connects transparency and pricing data back into government pricing and gross-to-net modeling so the same number tells the same story across compliance, finance, and access.
Channel choice locks in payer access economics, contract structure, government pricing exposure, and, once 867 data starts flowing, what your trade team can actually see and act on. The decision you make here echoes into every QBR for the next three years. It also drives whether the value, evidence, and payer story your access team has been building is even reachable through the chosen distribution path.
Where EPG fits: Two Labs leads channel design, 3PL and specialty partner selection, and ongoing trade operations. EPG Market Access, HEOR, Value & Evidence stress-tests channel design against payer mix, coverage strategy, and the value story the channel needs to support. Riparian translates the channel into contracting, chargeback validation, and gross-to-net implications so that revenue management isn’t reverse-engineered after launch.
Hub workflows are downstream of channel, payer, and REMS design, and upstream of adherence, refill rates, and the lived experience that determines whether a prescriber writes a second script. The most painful hub problems usually trace back to decisions made before the hub was even selected. PA, appeals, and copay logic are where market access meets the patient in real time.
Where EPG fits: Two Labs leads hub vendor selection, business rules design, agent training, call simulations, and post-launch quality monitoring. EPG Market Access, HEOR, Value & Evidence shapes prior authorization, appeals, and reimbursement workflows the hub has to execute against, and the value story field teams hand to payers. EPG Strategic Consulting aligns the hub experience with patient advocacy, brand strategy, and the broader patient journey.
Therapeutic classification in compendia doesn’t just affect prescribing. It shapes how payers see the product, how it benchmarks against competitors in coverage decisions, and what reimbursement looks like at the claim level. A misclassification fixed late costs months of access and pulls Riparian into restating government pricing assumptions. NDC and pricing data flow into compendia, EHRs, and government program reporting from the same source. If they don’t match, every downstream system disagrees.
Where EPG fits: Two Labs runs compendia submissions, EHRx visibility, and therapeutic classification defense. EPG Market Access, HEOR, Value & Evidence frames the clinical and economic story behind the classification, the version of the product payers and pathway committees will see. Riparian and Two Labs coordinate on NDC, labeler code, and pricing data so what gets submitted to compendia is the same dataset feeding government program calculations.
Where EPG fits: This section is the integration layer. Two Labs Strategic Consulting holds the integrated launch roadmap and cross-functional execution. Two Labs owns commercial and compliance execution day-to-day. EPG Market Access, HEOR, Value & Evidence connect payer and value realities back into design. Riparian closes the loop on revenue management, government pricing, and gross-to-net. The point isn’t four teams in four lanes. It’s one connected view of where a decision in one workstream is quietly setting an outcome in another.
Although the score gives you a good estimation of where you stand, the number matters less than where the gaps cluster. Look at which sections scored lowest, which individual questions you marked “No,” and where adjacent sections show weakness. That pattern is what tells you where risk is concentrating and where time is starting to work against you.
Schedule a 30-minute conversation and we’ll walk through your signal together: where risk is concentrated, where timing matters most, and where early action will save disproportionate pain later.
