Regulatory Affairs & Pharmacovigilance Services
Regulatory clarity. Across products and markets.
Standalone regulatory affairs, technical-documentation and product-safety support for manufacturers, product owners, trading companies, medical stores and other medical-products businesses across relevant markets. Warehouse use is not a prerequisite.
Discuss this serviceWho it is for
For businesses needing a defined regulatory assignment, dossier support, pharmacovigilance or device-vigilance work, or ongoing outsourced regulatory capacity without automatically changing their formal representation.
Four connected service areas
Regulatory Affairs & Product Registration
Product classification; relevant product and establishment applications; variations and renewals; regulatory submissions and correspondence; advertising permissions; lifecycle support; and municipality registrations where applicable.
Regulatory Dossiers & Technical Documentation
CTD/eCTD preparation, publishing and validation; dossier gap reviews; medical-device technical documentation; and submission support appropriate to the product and market.
Pharmacovigilance & Product Safety
Pharmaceutical pharmacovigilance, medical-device vigilance, safety-report work, risk-management support and outsourced safety functions where the required qualified resources are available.
Regulatory Outsourcing & Intelligence
Project-based or ongoing regulatory support, regulatory intelligence, multi-country assessments and appropriate specialist arrangements around a defined assignment.
Shape the assignment around the product
Product & market assessment
Clarify the product type, intended markets, responsible entities and regulatory objective before defining deliverables.
Focused deliverables
Agree whether the need is an application, dossier review, lifecycle task, safety assignment or ongoing regulatory support, including the customer inputs and interfaces required.
Appropriate safety terminology
Apply pharmacovigilance to pharmaceutical products and device-vigilance or other relevant product-safety requirements to the categories concerned.
What this helps you do
- Access a specific assignment or continuing support without a warehouse commitment.
- Coordinate regulatory documents, lifecycle tasks and product-safety work around the same agreed scope.
- Consider relevant markets with product-specific requirements and responsible entities in view.
Important scope qualifications
A standalone regulatory or safety assignment does not automatically establish a Main Pharmaceutical Establishment appointment or authorise physical import, storage or distribution. Scope depends on the product, country, responsible entities, applicable requirements and qualified specialist availability. Regulatory outcomes and authority approvals are not guaranteed.
Discuss this service
Tell us the product category, relevant markets and the regulatory or safety work you are considering.
Discuss this service