Clear promotional claims before local use

Connect proposed claims and artwork to approved indication, evidence and market label. Medical evaluates the substantiation with regulatory and legal reviewers before commercial distribution of the local version.

A notice, complaint, missed commitment or disputed amount opens a case.

People in the process

MMedical AffairsProcess Owner
RRegulatory AffairsParticipating Team
MMarketingParticipating Team
LLegalParticipating Team

Records it works with

Relevant agreement, policy or governing record
Transaction, performance and payment history
Notices, communications and supporting evidence

The process is a starting point.The standards are yours.

Configure by product, authorisation and destination market. Regulatory Affairs and authorised quality personnel retain product-change, submission and batch-release decisions. Safety reporting and UCPMP requirements use the applicable reviewed scope.

Keep the work connected.

Regulatory Affairs

Scope a product change across registered markets

Map proposed site, process, formula or specification changes to product dossiers, approved manufacturers and target markets. Regulatory affairs determines each filing route and implementation gate with QA before commercial rollout.

QMR

Regulatory Affairs

Reconcile approved artwork with every market version

Link label text, pack size, registration conditions and artwork proofs to the countries and batches concerned. Regulatory and QA approve cutover and stock disposition before packaging changes.

QPC

Regulatory Affairs

Answer authority queries from controlled source data

Collect the exact dossier version, study/report references and manufacturing changes behind an authority question. Regulatory authors a consistent response with technical owners and records the submission and commitments.

RQM

Explore all Pharma processes.

Order for the work. Room for the people.