Compliance
Compliance is insidethe work, notafter 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 come off the end of the timeline, where the conference 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 market, transfer-of-value treatment for HCP engagements, and personal data handling. The client’s medical, legal and regulatory reviewers then receive work with its predictable problems already removed.
What we do
What our review covers
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.
Promotional code positions
Assessment against the applicable code for the market: Egyptian requirements, GCC market codes, and global corporate policy where a multinational parent applies a stricter internal standard.
Transfer-of-value treatment
HCP engagement structured so that fair market value, contracting and spend capture are documented as the activity happens, not reconstructed for a disclosure deadline.
Data protection and consent
Personal data handling assessed against Egypt’s Personal Data Protection Law, and against GDPR where an EU or UK parent is in scope. Consent architecture is decided before a system is configured.
Pharmacovigilance touchpoints
Any activity that can surface an adverse event (social channels, patient programmes, market research, conferences) gets a documented escalation route agreed with your PV function before launch.
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, so final approval stays with you. What we remove is avoidable rework: the predictable rejections that eat review cycles without adding safety.
Why it matters
The enforcement picture has changed
Promotional compliance in pharma spent several years with little enforcement. That has reversed sharply, and organisations that built habits in the quiet period are exposed.
~100
FDA warning letters to pharmaceutical companies fell to one in 2023 and zero in 2024. In September 2025 the agency issued approximately 100 cease-and-desist letters and thousands of warning letters in a single action.
38.4 weeks
A peer-reviewed analysis of 18 years of UK PMCPA records found 1,797 cases ruled involving 159 companies, with average time to rule rising from 11.8 weeks in 2004 to 38.4 weeks in 2021.
Regulation & Governance (peer-reviewed), reported by The Pharmaceutical Journal, 2024
These figures are from US and UK regulators. They matter here 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, so final approval remains yours. Hibridge checks work internally so your MLR reviewers receive material with the predictable problems already removed.
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 local code for the market, plus your 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, 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.