Process Validation for paracetamol
Client Background: The manufacturer is one of the global producers of paracetamol medicine which is intended to treat fevers. Client
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Assembly of the GMP and regulatory requirement
Client Background: The manufacturer produces medicines in therapeutic areas such as Dermatology. The Dermatology medicine is intended to treat skin
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Obtaining an ISO 13485 Certificate
Client Background: Manufacturer produces devices replace bones, joint, or cartilage due to damage or deformity. The manufacturer of orthopedic implants
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Regulatory Publishing for the US
Client Background: The manufacturer is one of the global producers of cancer medicine which is intended to treat cancer patients.
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Pulse Oximeter FDA 510 (k) Approval
Client Background: The manufacturer produces devices which belongs to Class II used to measure the saturation of oxygen carried in
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Hiring and Setup of Regulatory and Quality Teams
Client Background: The client is manufacturer of Class IIb and Class III medical devices and intended to register their goods
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Clinical Study Report (CSR) for pharmaceuticals
Client Background: The client was a pharma manufacturer who produces medicines in different therapeutic areas such as Ophthalmology, Pulmonology, and
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Common Technical Document (CTD) Preparation for Canada
Client Background: The manufacturer is one of the global producers of diabetes medicine which is intended to treat diabetic patients.
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MDR Consulting & CER Writing for Colonic Stent
Client Background: The manufacturer is producer of Class III devices which are flexible, hollow tubes called colonic stents. The manufacturer
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Suction Catheter CE Certificate
Client Background: The manufacturer produces suction Cather which belongs to Class IIa and are suitable for clearing the airway in
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