Qplus consult
Qplus consult is a Belgian-based full-service pharmaceutical consultancy founded in 2010, specializing in pharmacovigilance, medical writing, quality management, regulatory affairs, auditing, training, and GDP compliance. The company is committed to providing high-quality, flexible, and tailored services to support the pharmaceutical industry in ensuring the safety, efficacy, and quality of medicines and medical devices. With a focus on compliance, continuous improvement, and long-term client relationships, Qplus consult leverages extensive expertise and industry best practices to help clients achieve regulatory success and operational excellence. The company values client first, dedication, loyalty, passion, professionalism, and performance, and aims to build long-term relationships with its clients.
Industries
Nr. of Employees
small (1-50)
Qplus consult
Products
Regulatory Affairs
Comprehensive regulatory affairs consultancy services including marketing authorisation management, dossier maintenance, and lifecycle monitoring.
Self inspections and supplier audits
Internal and external audit services performed by independent auditors to ensure compliance with European and national regulations, verifying the quality of processes, products, and capacity.
Medical Writing Services
Professional medical writing services for regulatory affairs, medical communication, and marketing communication, including scientific documents and regulatory dossiers.
EU Qualified Person for Pharmacovigilance (QPPV)
Contracted EU Qualified Person responsible for Pharmacovigilance (QPPV) and/or Deputy services ensuring full compliance with European and national regulations.
Pharmacovigilance System & Pharmacovigilance System Master File (PSMF)
Development, establishment, and maintenance of a complete pharmacovigilance system and Pharmacovigilance System Master File (PSMF) tailored to your organization.
Adverse Event Management and expedited reporting to EudraVigilance
Comprehensive adverse event case management supporting (bio)pharmaceutical companies with compliance, from receipt and recording to medical assessment, follow-up, and expedited reporting via EudraVigilance.
Regulatory Affairs
Comprehensive regulatory affairs consultancy services including marketing authorisation management, dossier maintenance, and lifecycle monitoring.
Self inspections and supplier audits
Internal and external audit services performed by independent auditors to ensure compliance with European and national regulations, verifying the quality of processes, products, and capacity.
Medical Writing Services
Professional medical writing services for regulatory affairs, medical communication, and marketing communication, including scientific documents and regulatory dossiers.
EU Qualified Person for Pharmacovigilance (QPPV)
Contracted EU Qualified Person responsible for Pharmacovigilance (QPPV) and/or Deputy services ensuring full compliance with European and national regulations.
Pharmacovigilance System & Pharmacovigilance System Master File (PSMF)
Development, establishment, and maintenance of a complete pharmacovigilance system and Pharmacovigilance System Master File (PSMF) tailored to your organization.
Adverse Event Management and expedited reporting to EudraVigilance
Comprehensive adverse event case management supporting (bio)pharmaceutical companies with compliance, from receipt and recording to medical assessment, follow-up, and expedited reporting via EudraVigilance.
Services
End-to-end pharmacovigilance support including case management, expedited reporting, pharmacovigilance system setup and maintenance, signal management, periodic safety reports and risk management planning, and vigilance for devices, cosmetics and supplements.
Preparation and review of regulatory and medical documents including clinical study reports, summaries and overviews, CTD Module 2 content, IMPDs, PSURs, RMPs and safety narratives, aligned with regulatory formats and guidance.
Management of regulatory submissions, marketing authorisation applications and variations, dossier lifecycle activities, submission formatting and coordination with national and regional authorities.
Design and maintenance of quality management systems, advisory support for GMP and GDP implementation, ISO alignment, supplier qualification and support for designation and responsibilities of Qualified/Responsible Persons.
Execution of internal and external audits, supplier audits, computerized systems validation reviews, mock inspections and remediation planning to support regulatory inspections and quality compliance.
Tailored training courses and e-learning/webinar programmes on pharmacovigilance, GxP, quality management and regulatory topics, delivered via online platforms or in-company.
End-to-end pharmacovigilance support including case management, expedited reporting, pharmacovigilance system setup and maintenance, signal management, periodic safety reports and risk management planning, and vigilance for devices, cosmetics and supplements.
Preparation and review of regulatory and medical documents including clinical study reports, summaries and overviews, CTD Module 2 content, IMPDs, PSURs, RMPs and safety narratives, aligned with regulatory formats and guidance.
Management of regulatory submissions, marketing authorisation applications and variations, dossier lifecycle activities, submission formatting and coordination with national and regional authorities.
Design and maintenance of quality management systems, advisory support for GMP and GDP implementation, ISO alignment, supplier qualification and support for designation and responsibilities of Qualified/Responsible Persons.
Execution of internal and external audits, supplier audits, computerized systems validation reviews, mock inspections and remediation planning to support regulatory inspections and quality compliance.
Tailored training courses and e-learning/webinar programmes on pharmacovigilance, GxP, quality management and regulatory topics, delivered via online platforms or in-company.
Expertise Areas
- Pharmacovigilance management and safety reporting
- Regulatory affairs and dossier lifecycle management
- Medical writing and scientific communication
- Quality management and GxP/GDP frameworks
Key Technologies
- Pharmacovigilance databases and signal detection systems
- Safety data statistical analysis
- Clinical dossier preparation and electronic submission formats (CTD/ectd/neeS)
- Medical literature screening and monitoring tools
News & Updates
An article discussing the role, duties, qualification, training, and responsibilities of the Responsible Person for GDP, emphasizing the importance of a qualified and trained individual to ensure GDP compliance.
Information about the designation process for Responsible Persons for GDP, highlighting the importance of this role in ensuring GDP compliance.
An overview of the European guidelines governing the manufacturing of medicinal products, focusing on GMP principles, quality control, and compliance requirements for pharmaceutical companies operating in the EU.
An article highlighting the importance of quality, safety, and efficacy in medicines, discussing quality assurance activities, phases, consequences of non-compliance, and the role of Qplus consult in supporting pharmaceutical quality systems.
An article explaining the critical role of quality assurance in ensuring medicines are safe, effective, and of high quality, covering phases, consequences of poor quality, and key activities involved.
An overview of the EU regulations and guidelines that govern pharmaceutical manufacturing, emphasizing the principles of GMP, quality control, and compliance.
An article discussing the role, duties, qualification, training, and responsibilities of the Responsible Person for GDP, emphasizing the importance of a qualified and trained individual to ensure GDP compliance.
Information about the designation process for Responsible Persons for GDP, highlighting the importance of this role in ensuring GDP compliance.
An overview of the European guidelines governing the manufacturing of medicinal products, focusing on GMP principles, quality control, and compliance requirements for pharmaceutical companies operating in the EU.
An article highlighting the importance of quality, safety, and efficacy in medicines, discussing quality assurance activities, phases, consequences of non-compliance, and the role of Qplus consult in supporting pharmaceutical quality systems.
An article explaining the critical role of quality assurance in ensuring medicines are safe, effective, and of high quality, covering phases, consequences of poor quality, and key activities involved.
An overview of the EU regulations and guidelines that govern pharmaceutical manufacturing, emphasizing the principles of GMP, quality control, and compliance.