Leaders in Promotional Compliance
OPDP and APLB read your promotion the way a reviewer reads a submission: claim by claim, against the label, against the data, and against everything your competitors have been cited for. One overstated benefit or buried risk statement can pull a campaign, trigger an untitled letter, and stall a launch your company spent a decade reaching. We put senior medical, regulatory, and legal reviewers inside your MLR process, so materials move fast because they are right, not because nobody looked closely.
We support the full lifecycle of a promotional asset: the committee that reviews it, the substantiation behind it, the submission that accompanies it, and the response strategy when the agency pushes back.
Chairing, staffing, and running PRC / MLR committees that clear material on schedule, from standing reviewer seats to full committee operations.
Claim-by-claim verification that every statement is scientifically accurate, consistent with the label, and supported by the cited evidence.
Risk presentation, comparative claims, and fair balance assessed the way OPDP will assess them, before the material leaves the building.
Form 2253 submissions at time of first use, eCTD-format ad/promo packages, and advisory comment requests, filed on time with a clean record.
Websites, paid search, social platforms, and influencer programs reviewed for channels where space is short and enforcement is active.
Untitled letter and warning letter response, corrective messaging, and the process remediation that keeps the second letter from arriving.
Most MLR bottlenecks are not compliance problems; they are operations problems. Reviewers without clear standards re-litigate the same claim on every asset, agendas slip, and marketing learns to route around the process. We run promotional review committees as an operating discipline: defined standards, claim libraries that settle arguments once, service-level turnaround targets, and senior reviewers with the authority to make a call and move on.
A claim can be technically true and still be misleading: a secondary endpoint presented as primary, a subgroup result generalized to the population, a p-value carrying more weight than the study design allows. Our physicians and PharmDs review every claim against the approved labeling and the underlying evidence, verify that references actually support the sentences they are attached to, and document the substantiation so the file stands on its own in an audit or an agency inquiry.
OPDP enforcement follows patterns: risk information that is present but minimized, efficacy claims broader than the indication, comparisons no head-to-head trial supports. We review your materials against the regulations, the guidance, and the current enforcement record, applying the same claim-by-claim scrutiny the agency applies, and we put our reasoning in writing so marketing understands not just what changed, but why it had to.
Every piece of promotional labeling and advertising for a prescription product goes to FDA on Form 2253 at the time of initial dissemination, and products under accelerated approval face pre-dissemination review on top of it. We manage the entire submission operation: assembling the package, publishing it in eCTD format, dispatching it to OPDP or APLB, and maintaining the tracking record that proves each piece was filed when the regulation says it had to be.
A paid search ad has ninety characters and the same fair balance obligation as a journal spread. A sponsored influencer post is promotion, with your name on it, the moment the contract is signed. We review digital and social programs for how the rules actually apply in each format: what risk information must travel with the claim, what a character-limited placement can and cannot say, and where a share, an edit, or a comment thread turns someone else's speech into yours.
An untitled letter gives you days, not weeks, to respond, and the response sets the tone for everything after it: whether the matter closes quietly, escalates to a warning letter, or triggers corrective advertising. We build the response strategy, draft the correspondence, negotiate the corrective actions, and then fix the review process that let the piece through, because the agency's second letter is never as polite as its first.
Two situations put the most pressure on a review process: the first commercial launch, and the decision to build a review function where none exists.
Launch is when material volume peaks, the claims are newest, and OPDP is watching most closely, and for accelerated approval products, promotional materials face agency review before they can be used at all. We build the promotional foundation ahead of approval: the core claims matrix mapped to the anticipated label, the launch material pipeline sequenced through review, and the submission plan that keeps day-one marketing legal on day one.
First-launch companies usually discover they need an MLR process about six months after they needed one. We build the function end to end: the charter and SOPs, the e-review system, the claim library, the reviewer roles, and the training that teaches marketing and agency partners to write compliant material the first time, then we staff it until your own team is ready to take it over.
Our review teams combine former FDA staff who evaluated promotional materials from the agency side with industry veterans who have chaired promotional review committees through launches, label changes, and enforcement actions. You get the senior practitioner at the table, not a junior team under a partner's name.
Reviewers who have handled OPDP correspondence from both sides of the table know which claims draw comment letters, because they have seen how the agency builds one.
Physicians, PharmDs, regulatory strategists, and promotional compliance attorneys who each hold their own seat on your committee, so no single perspective gets outvoted by momentum.
Deep working experience in Veeva PromoMats and the other major e-review systems, from daily reviewer workflows to full implementation and migration.
Prescription drugs, biologics, medical devices, diagnostics, OTC products, and combination products, across oncology, rare disease, immunology, neuroscience, and beyond.
Tell us where your program stands: pre-launch, mid-campaign, or mid-remediation, and what your material volume looks like. We'll match you with a senior review lead and respond within one business day. All inquiries are strictly confidential.
Our team's perspectives on OPDP enforcement, MLR operations, and what actually gets a campaign in trouble: coming soon. In the meantime, reach out directly with a question you'd like to see addressed.
The claim patterns behind recent OPDP enforcement, and how to screen for them in review.
How risk presentation obligations apply to paid search and space-limited digital formats.
Where launch teams most often miss the time-of-dissemination requirement, and how to build a calendar that doesn't.