Welcome to the PharmaMediQ services page! Here you will find information about our consulting services in the medical device and medicine areas of regulatory affairs, GxP Audit and Pharmacovigilance consulting, product and market strategies.

Regulatory Affairs

Medical device and medicine approval consulting will help you to have a clear picture of  regulatory routine and approval procedures in different countries and territories.

  • Regulatory support and compliance check
  • Comprehensive approval procedures
  • Standard Operating Procedures (SOPs) construction and optimization for compliance to local law
  • Wholesale License application and Warehouse inspection
  • Advice to special or urgent requests from competent authorities

GxP Audit and Pharmacovigilance

GxP audit requirements refer to the guidelines and standards that ensure the quality and compliance of life sciences organizations, particularly those involved in pharmaceuticals, medical devices, biotechnology, and food industries. 

  • Training & Personnel Qualification
  • Risk assessment
  • Corrective and Preventive Actions (CAPA) strategies
  • Standard Operating Procedures (SOPs) implementation

 

The pharmacovigilance consulting will help you monitor and evaluate safety aspects of medicines to minimize risks.

  • Construction and optimization of Risk Management Plans (RMP)
  • Advise to Pharmacovigilance System Master File (PSMF)
  • Pharmacovigilance Audits and Inspections support
  • Advice to reporting and response to Health authority for safety issues

Product and Market Strategies

Our consulting service could provide or optimize the strategies when bring a medical product to a market. The advice and product/project incubation will also helps your to solve the problem or the release the bottleneck of your current business.

  • Effective marketing accessing strategies
  • Product incubation (medical device, drug, food supplement, special pharmaceutical foods, special cosmetic)
  • Project plan, establishing and processing
  • To expand custom product in the target market and find more potential chances
  • Find appropriate  business Location (office, warehouse etc.), manufacturers and suppliers

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