Translate new requirements into affected registrations

Compare a reviewed regulatory update with market licenses, dossier commitments, artwork and planned changes. Regulatory prioritizes products needing variation, evidence or customer notification.

A proposed change affects an approved product, process, contract or operating plan.

People in the process

RRegulatory AffairsProcess Owner

Records it works with

Change request and current approved baseline
Affected agreements, policies and operating records
Technical, commercial and regulatory assessments

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.