Pathway & legal-basis mapping
Structure the target territory, product status, intended procedure and questions that need qualified assessment before an application plan is fixed.
Medicines regulatory affairs
Regulatory affairs & marketing authorisation support.
Riverpharma helps medicine developers, manufacturers, applicants and marketing authorisation holders structure UK and EU regulatory workstreams—from pathway and dossier readiness to submission planning and post-authorisation change coordination.
Support is advisory and project based. The applicant or marketing authorisation holder, its qualified experts and the competent authority retain every formal declaration, submission and decision.
What we support
From route selection to lifecycle control.
Each engagement is defined around the product, jurisdiction, responsible legal entity and stage of the regulatory lifecycle.
Dossier-readiness coordination
Map CTD or eCTD workstreams, evidence owners, product-information materials, dependencies and gaps against the agreed submission plan.
Submission workstream planning
Coordinate milestones, document readiness, technical validation inputs and authority-question tracking while formal submissions remain with the authorised applicant or holder.
Post-authorisation lifecycle support
Organise variation, renewal, transfer and product-information change workstreams with clear ownership, dates and decision points.
Working model
One regulatory plan, with ownership kept explicit.
We turn an open-ended requirement into a visible programme of evidence, documents, responsibilities and controlled milestones.
- 01
Scope
Confirm the product, territory, current status, intended procedure, target milestone and responsible legal entity.
- 02
Plan
Translate the requirement into workstreams, dependencies, evidence owners, authority touchpoints and a controlled timeline.
- 03
Coordinate
Keep documents, questions, actions and review cycles visible to the applicant, holder and appointed specialists.
- 04
Maintain
Track agreed submission and lifecycle milestones without displacing formal ownership or regulatory accountability.
Operating boundary
Regulatory support never becomes regulatory authority.
Riverpharma is not the MHRA, EMA, European Commission or another competent authority. It does not act as the applicant, marketing authorisation holder or legal representative and does not give product-specific legal, medical or scientific advice.
The responsible applicant or holder owns the data, dossier, declarations, formal submissions, fees, pharmacovigilance duties and product lifecycle. Regulators alone determine requirements, validation, assessment timetables and outcomes; authorisation is never guaranteed.