Our regulatory affairs consulting services include pharmaceutical, medical device product registration, traditional medicine and health products listing with the regulatory authorities. We can assist in preparing and reviewing of technical dossiers for submission and assist in handling enquiries from the regulatory authorities.
We assist companies in classifying and grouping of medical devices (MD) and develop the best strategy for MD product registration. We can help you to prepare registration dossier based on your existing CE-Marked Technical Dossier, US FDA 510K submission documents, Japan MHLW application.
We can help you in reviewing Chemistry Manufacturing Clinical (CMC) data for use in product registration,
- preparing Common Technical Dossier in the necessary format (ICH, ASEAN CTD),
- NDA, GDA, MAV (New Drug Application, Generics Drug Application, Major Variation Application ).
Medicinal Products Registration
Medical Device Product Registration
Handling of Regulatory Agencies Enquiries
Post-Marketing Surveillance Management
Field Safety Corrective Action Management
Handling Enforcement