Get regulatory work done, anywhere.
Access standalone regulatory services across countries and industries. View price, buy, upload documents and track progress. Complex programmes are scoped and priced individually.
Medical Device Classification: EU
Rule-by-rule classification under MDR 2017/745 with a written rationale memo.
UK Cosmetic Label Review
Ingredient, claims and format review against UK Cosmetics Regulation.
Regulatory Strategy Assessment
Pathway options, precedent review and a recommended route to market.
Pharmaceutical Market Entry
End-to-end market authorisation programme with local representation.
SaMD Classification & Pathway: UK
Classification, applicable standards and UKCA route definition.
CMC Dossier Gap Assessment
Module 3 review with a prioritised gap and remediation list.
Authorised Representative: Saudi Arabia
Local authorised representation and SFDA account management.
Chemical Compliance Dossier: UAE
Safety documentation set and import compliance review.
Regulatory Due Diligence: Target Review
Portfolio, approvals and compliance risk review for transactions.
ASEAN Registration Programme
Multi-country registration planning and submission management.
Indian CMO Sourcing & Assessment
Longlist, regulatory assessment and shortlist of manufacturing partners.
Singapore Local Registrant Setup
Local registrant appointment and HSA submission preparation.