Regulatory Advice/Due Diligence
- Consultation/ advocacy with relevant authorities and or other related organization/ institution on the Client’s case.
- Reviewing regulation/ literature/ Client’s document.
- Provide options and recommendation to Client.
- Provide a roadmap of improvement/ establishment of Client’s project.
Product Registration/ Notification
- Dossier screening and consultation to relevant authority with regards to the project.
- Dossier preparation and uploading to online submission system (whenever applicable).
- Submission and follow up, until the original certificate is obtained.
- PIF establishment (for Cosmetics product).
License Holding (Local Authorized Representative/ Registrant)
- Being the legal representative on behalf of the Client.
- Maintain the validity of the product license.
- Ensure the Distributor complies with the requirements of GDP.
Manage field corrective action (i.e. : product recall, notification to relevant authority), adverse event reporting, communication with relevant regulatory authority, and manage Post Market Surveillance.
- Performing importation, with the support of appointed freight forwarder and custom broker.
Distribution Services (Box Mover)
- Logistic and Transportation
- Inventory Management
- Order Processing/ Invoicing and Correction
Quality Management System
- 3rd party audit for internal compliance purpose or preparation of certification (ISO, GMP and other 3rd party certification)
- Establishment/ improvement of Quality Management System in manufacturing facility
- Contract Manufacturing
- Sterilization Services (ETO)
- Packaging Services
- Laboratory Services (Sterility Testing, ETO Residual Testing, Stability, etc)
- Clinical Trials
- Getting Ethical Committee Approval
- Getting Special Access Scheme from MoH
- Performing the importation
- Halal Certification
- Medical Translation
- General Translation
- After Sales Service
- Servicing and Maintenance Medical Equipment