Regulatory Affairs Consulting Services

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.

 

Medical Device Registration

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.

 

 

Medicinal Product Registration

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 ).

 

 

Regulatory Affairs

Medicinal Products Registration

Medical Device Product Registration

Handling of Regulatory Agencies Enquiries

 Post-Marketing Surveillance Management

Field Safety Corrective Action Management

Handling Enforcement