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Pricing and offer:
- You can buy any single SOP or Bundle offer through this Website , or send us email to info@upbeatconsult.com, and will send you an invoice and process your order after receipt of payment
- Price for each SOP as shown below
- If You order Four SOPs , You Get 15% Disocunt on Total Price
- Bundle offer : If You Order the Full set of SOPs , there will be 40% Disocunt on Total Price
- The SOPs will be Sent to your Email as a Soft Copy (PDF or Word File) in 3-4 days
- The Price includes One Assistance Free for Local Customization to Your Company
SOPs List Available
Collection, Assessment, Processing of Adverse Events and SAEs
Aggregate Reporting - PSUR
Literature Screening
Scope of SOP
Detection of adverse event case reports through routine surveillance of scientific and medical literature
Buy $ 99
Implementation of safety variations to SmPC and patient information leaflets
Scope of SOP
Describe Procedure of Implementation of safety variations to SmPC and patient information leaflets
Buy $ 101
PV Training
Scope of SOP
The establishment of training requirements to ensure that the staff engaged in activities related to AE processing is trained
Buy $ 99
Signal Detection and Risk Management
Scope of SOP
The assessment of and update to the risk-benefit profile for company products
Buy $ 199
QPPV Role and Responsibilities
Scope of SOP
Describes the role and responsibilities of the QPPV and Deputy for marketed products.
Buy $ 99
PSMF Development
Scope of SOP
Describes activities & responsibilities Required for preparation, review, approval & maintenance of PSMF
Buy $ 199
Safety Data Exchange Agreements
Scope of SOP
Preparation & revision of Safety Data Exchange Agreements with business partners of the company
Buy $ 199
Product Quality Complain Issues, Recall or Withdrawal
Scope of SOP
Define the procedure and timeline regarding products quality compalin issues, and recalls or withdrawals
Buy $ 199
Communication of Safety Concerns to Consumers
Scope of SOP
The process of communication of safety concerns to consumers, healthcare professionals & national medicines authorities
Buy $ 99
Deviation Documentation
Scope of SOP
The management, processing, review, approval, and closeout of SOP deviations, planned or otherwise
Buy $ 199
SOP on SOPs
Scope of SOP
The format, responsibilities, approval, periodic review, maintenance, & usage of controlled documents
Buy $ 99
CAPA Processes for PV
Scope of SOP
The CAPA System which apply to Dept.audit that involve deviations regarding regulations of established procedures
Buy $ 199
Good Documentation Practices
Scope of SOP
The minimum standards for GDoP and ensures that errors are properly corrected and noted as to their nature.
Buy $ 199
Management of Inspections
Scope of SOP
The responsibilities, conduct,& activities during the local regulatory inspections & post-inspection responses to findings and observations.
Buy $ 99
Document Retention
Risk Management System(s) and Monitoring of the outcome of Risk Minimisation Measures.
Scope of SOP
Describe the procedure of Risk Management System(s) and monitoring of the outcome of risk minimisation measures
Buy $ 199
