Pharmacovigilance
“Pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem”. World Health Organization
Our Pharmacovigilance services include:
- Qualified Person for Pharmacovigilance (QPPV), Deputy and Local Pharmacovigilance Contact Person
- 24/7 contact availability
- Pharmacovigilance System Master File (PSMF)
- Management of Adverse Events / Safety Information
- Pharmacovigilance Agreements
- Risk Management Plans / Risk Minimization Activities
- Aggregate Reporting [i.e. Periodic Safety Update Reports (PSUR) and Development Safety Update report]
- Signal Detection
- Global/Local Literature Screening
- Audits and Inspection Readiness
- Standard Operating Procedures (SOPs) for Pharmacovigilance
Materiovigilance
“Materiovigilance is the study and follow up of incidents that might result from using medical devices. It enables dangerous devices to be withdrawn from the market and to eliminate faults in medical devices with the intention of constantly improving the quality of devices and providing patients and users with increased safety”. Federal Agency for Medicines and Health Products
Our Materiovigilance services include:
- Materiovigilance Contact Person
- Management of Incidents with Validated Database
- Materiovigilance Agreements
- Audits and Inspection Readiness
- Standard Operating Procedures (SOPs) for Materiovigilance
- Materiovigilnace Training
Cosmetovigilance
“Cosmetovigilance is defined by the collection, evaluation and monitoring of spontaneous reports of undesirable events observed during or after normal or reasonably foreseeable use of a cosmetic product. Together with other tools, cosmetovigilance contributes to post market surveillance”. European Commission
Our Cosmetovigilance services include:
- Cosmetovigilance Contact Person
- Management Undesirable Effects with Validated database
- Cosmetovigilance Agreements
- Audits and Inspection Readiness
- Standard Operating Procedures (SOPs) for Cosmetovigilance
- Cosmetovigilance Training
Quality Management
“Quality Management is the act of overseeing all activities and tasks needed to maintain a desired level of excellence”
Our Quality Management services include:
- Quality System Development, Assessment and Optimization
- Preparation and Optimization of Policies / Standard Operating Procedures
- Implementation and Management of agreements / contracts
- Quality Risk Management
- Execution and Coordination of Audits
- Supporting Inspection readiness
- Training Management
Quality Assurance
“Quality Assurance is the total sum of the organized arrangements made with the object of ensuring that medicinal products are of the quality required for their intended use” (Directives 2003/94/EC)
Our Quality Assurance services include
- Quality System Development, Assessment and Optimization
- Preparation and Optimization of Policies / Standard Operating Procedures
- Implementation and Management of agreements / contracts
- Quality Risk Management
- Execution and Coordination of Audits
- Supporting Inspection readiness
- Training Management
Medical / Scientific Translation and Proof-Reading
Our Medical / Scientific Translation and Proof-Reading services include:
- Medical / Scientific publications
- Pharmacovigilance source documents (e.g. medical / hospital records, hospital discharge papers, etc.)
- Clinical Protocols / Study Reports / Informed Consent Forms
- Risk Minimization Plans / Activities
- Educational Materials for Healthcare Professionals / Patients
- Summary of Product Characteristics / Patient Information Leaflets
- Product / Scientific / Corporate Presentations
