Compliance
Compliance is inside the work, not after it.
Most agencies treat compliance as the client’s problem. The work is produced, submitted, rejected, revised, resubmitted. Each cycle costs a week, and the weeks are always taken from the end of the timeline — which is where the congress date sits.
In short
Hibridge operates an in-house pharmaceutical compliance team that reviews every deliverable before it is sent to the client. Review covers scientific claim substantiation against the approved label, promotional code positions for the relevant market, transfer-of-value treatment for HCP engagements, and personal data handling. The intent is that the client’s medical, legal and regulatory reviewers receive work with its predictable problems already removed.
What our review covers
01
Scientific claim substantiation
Every claim traced to the approved label or to a referenced, on-file source. Claims that cannot be substantiated are removed at the drafting stage rather than defended at review.
02
Promotional code positions
Assessment against the applicable code for the market in question — Egyptian requirements, GCC market codes, and global corporate policy where a multinational parent applies a stricter internal standard.
03
Transfer-of-value treatment
HCP engagement structured so that fair market value, contracting and spend capture are documented as the activity happens, not reconstructed afterwards for a disclosure deadline.
04
Data protection and consent
Personal data handling assessed against Egypt’s Personal Data Protection Law and, where an EU or UK parent is in scope, against GDPR. Consent architecture is decided before a system is configured.
05
Pharmacovigilance touchpoints
Any activity that can surface an adverse event — social channels, patient programmes, market research, congresses — gets a documented escalation route agreed with your PV function before launch.
06
Audit trail
Every deliverable arrives with its review record. If a regulator or an internal audit asks how a claim was approved, the answer exists as a document rather than a memory.
What we do not claim
We do not approve materials on your behalf, and we do not replace your MLR process. Regulatory accountability sits with the marketing authorisation holder and cannot be outsourced. What we remove is the avoidable rework — the predictable rejections that consume review cycles without adding safety.
The enforcement picture has changed
Promotional compliance in pharma spent several years in a low-enforcement environment. That has reversed sharply, and organisations that built habits during the quiet period are exposed.
~100
U.S. Food and Drug Administration ·
38.4 weeks
Regulation & Governance (peer-reviewed), reported by The Pharmaceutical Journal ·
Sources
Every figure on this page is attributed to its original publisher. Where a figure is organiser-reported or secondary, we say so.
These figures are from US and UK regulators. They matter regionally because multinational corporate policy is usually written to the strictest standard the group faces, and that standard is then applied to Egyptian and GCC affiliates.
Frequently asked questions
- Does Hibridge approve materials on our behalf?
- No. Regulatory accountability sits with the marketing authorisation holder and cannot be transferred to an agency. Hibridge pre-clears work internally so that the client’s MLR reviewers receive material with predictable problems already removed. Final approval remains yours.
- What qualifies your compliance team?
- The team is staffed by reviewers with in-house pharmaceutical experience — people who have sat on the client side of an MLR process rather than only submitted into one.
- Which codes do you work against?
- The applicable local code for the market, plus the client’s own corporate policy where it is stricter, which for multinational affiliates it usually is. We ask for your internal standard at kick-off rather than assuming the local minimum.
- Does this slow delivery down?
- It moves the review earlier, not later. Compliance positions are resolved during design, which is when changing them is cheap. The cost lands in week one instead of week nine.
- Can you work with our existing MLR platform?
- Yes. We prepare submissions in the format your platform and reviewers expect, including modular content structures where you use them.
Bring us the process that keeps slipping.
Usually it is a congress, a launch pack, or a social channel nobody wants to own.