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)
- Warehousing
- 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
- Contract Manufacturing
- Sterilization Services (ETO)
- Packaging Services
- Laboratory Services (Sterility Testing, ETO Residual Testing, Stability, etc)
Other Services
- Clinical Trials
- Getting Ethical Committee Approval
- Getting Special Access Scheme from MoH
- Performing the importation
- Halal Certification
- Translation
- Medical Translation
- General Translation
- After Sales Service
- Servicing and Maintenance Medical Equipment
- Training and Developments
As technology advances and workplace strategies evolve, there comes a need for professionals to align with these changes in terms of knowledge and skills. One of the best ways to enhance knowledge and skills is through training & development, continuous learning activities by providing employees with relevant and consistent training to enhance the knowledge, improve employee skills and confidence in their ability to perform their task more effectively and efficiently.
Continuous learning provides information and instruction on how to better perform specific tasks in the current challenging environment. This increases an
individual’s awareness and motivation to perform their job well. It is therefore important for organizations to continually and consistently upgrade the knowledge and skills of their human capital through training and development to reduce employee turnover, and improve company culture to remain competitive in the global arena.
In Sixmurs, we are committed in providing its expertise to help its client equipped with the knowledge and skills to ensure they stay competitive in the market. Sixmurs is approved training provider with HRDF and our trainers & courses are registered with HRDF. We help companies provide effective employee training & development opportunities.
