HKBtech provides pharmacovigilance-focused support for ongoing literature surveillance obligations.
We support pharmaceutical companies with the weekly identification, review, and documentation of product-related literature in line with established pharmacovigilance expectations.
Our focus is not on replacing internal pharmacovigilance judgment, but on supporting the process and outputs that underpin inspection readiness.
The outputs generated are structured to support common regulatory expectations for ongoing literature surveillance. The emphasis is on consistency, traceability, and contemporaneous documentation, rather than tooling or automation.
Important: HKBtech does not make adverse event determinations. All clinical and regulatory judgments remain with the client’s pharmacovigilance function.
Our support is typically used by small to mid-sized pharmaceutical companies that:
Engagements typically begin with a short, exploratory discussion focused on the existing literature surveillance process and how weekly outputs are currently documented.
Where appropriate, HKBtech can perform a limited pilot or shadow run alongside existing processes. This allows teams to review outputs without disruption, commitment, or change to current responsibilities.
Contact: www.hkbtech.co.za
Ongoing literature surveillance forms part of routine pharmacovigilance obligations and is subject to inspection. While approaches vary between organisations, inspectors typically expect that weekly searches are performed, reviewed by appropriately qualified personnel, and documented in a manner that allows reconstruction of decisions.
HKBtech supports weekly literature surveillance by providing structured identification and presentation of product-related publications, with documented outputs suitable for PV review and retention. All safety assessments and regulatory decisions remain with the client.