Process Validation for paracetamol
Client Background: The manufacturer is one of the global producers of paracetamol medicine which is intended to treat fevers. Client Problem: Manufacturer needed support for process validation to get acceptance…
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 disorders. Client Problem: The manufacturer needed support in the GMP…
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 is intended to be used as fixation implants for bone…
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. Client Problem: Manufacturer needed support for End – To- End…
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 red blood cells. The manufacturer of Class II for the…
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 in international markets. To catalyse their product launch they needed…
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 Dermatology. Problem: They were facing issues in preparing the CSR…
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. Client Problem: The manufacturer needed assistance in CTD preparation as…
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 of Class III Colonic stent is intended to treat obstructed…
Suction Catheter CE Certificate
Client Background: The manufacturer produces suction Cather which belongs to Class IIa and are suitable for clearing the airway in patients. It is intended for removing secretions from mouth/ pharynx/trachea/bronchial…
