Services

Act as your LTR

• To meet TMDA regulatory requirements to attain Marketing Authorization.
• To facilitate all communications between the applicant and TMDA.
• To Assist in Product Retention Process in Time.
• To help find suitable distributors for your products.

Pre- Market Authorization Support-Through

• Dossier Review and compilation
>> Review your CTD or eCTD Product Dossier to make sure all sections applicable including the administrative information, product information, quality, non-clinical and clinical data contain all information required before submission.
>> Proper Compilation of CTD or eCTD dossier by the requirements.

• Online submission of CTD Dossier for Human Medicines, Complementary Medicine, Orphan Medicine, Veterinary Medicines, Medical Devices, and IVDs.

• Review, compilation, and Submission of Registration Documents for your Food Supplement and Cosmetics.

• Follow up with Authority
>> Proper follow-up with the Authority to ensure timely product registrations.

Post-Approval Support

• Variations - Changes to the registered dossier are necessary throughout the life cycle of your medicinal product. Changes are mostly administrative or technical and such change will mean that a variation application will need to be submitted to the relevant Health Authority
We will assist by
>> Authoring and submitting the necessary documentation for variations
>> Suggesting the optimum variation strategy encompassing the required changes (type of variation, timing, and grouping options)

• Renewals – Marketing Authorizations have a validity of five years. Therefore, as an MA Holder, you will need to submit a Renewal product application.
We will assist by
>> Preparing and submitting the renewal application
>> Advising on setting the optimum renewal date (common renewal or early renewal)

• Pharmacovigilance
• Import permits

Pharmacovigilance

Serve as local Pharmacovigilance Agent
>> To establish and maintain of PV system
>> To Prepare the PV Master file
>> To Manage PV System throughout the entire life cycle of the product.