top of page
_DSC0825.jpg

QUALITY ASSURANCE

Why choose KS Pharma Services?

With our extensive experience across diverse types of pharmaceutical organizations, KS Pharma Services offers you a wide range of services to optimize your company's quality management practices. We support pharmaceutical companies in building and maintaining robust Quality Assurance systems that ensure consistent compliance and product excellence. Quality Assurance is not just a regulatory requirement — it is a strategic commitment to delivering trust and value.

​

​

Our Quality Assurance services include:​​​

Analysis

Gap analysis and audits of existing quality systems.​

​

​

Standard Operating Procedures

Development, review, and optimization of Standard Operating Procedures (SOPs).

​

Quality Management System

Implementation and improvement of Quality Management Systems (QMS) tailored to your organization (GMP, GDP, ISO 13485, etc.)

​

Training

We offer training programs to foster a quality-driven culture across your teams.

​

​

Continuous improvement strategies

We can help you with the integration of quality metrics and feedback systems.

​

​

Inspection and certification

Support for regulatory inspections and preparation for GMP/GDP certification.

​

 

KS Pharma Services also offers you expertise in digitalizing quality processes. Through our specialized software solutions, we help you implement efficient electronic Quality Management Systems (eQMS), enabling better document control, streamlined workflows, and full regulatory compliance. 

​

​

Partner with KS Pharma Services to future-proof your QA systems, strengthen your organization's reputation, and drive sustainable success in a competitive market.

 

​

Good Manufacturing Practices (GMP) – Qualified Person (QP) To ensure the Good Manufacturing Practices (GMP) of your pharmaceutical activities, you rely on a Qualified Person (QP). A QP is a legally designated role responsible for certifying that each batch of medicinal product meets the required quality standards before it can be released to the market. With our team of experienced QPs, we provide comprehensive support throughout the entire product lifecycle. At KS Pharma Services, we offer a range of services tailored to your company's specific needs. Our QPs work closely with your team to review and assess your quality systems, ensuring they align with current GMP requirements. By engaging our QPs, you benefit from their expertise in navigating complex regulatory landscapes, greatly reducing the risk of non-compliance and potential product recalls. We are committed to ensuring the safety, efficacy, and quality of your medicinal products and manufacturing activities, while enabling you to focus on your core business objectives. Partner with us to harness the knowledge and guidance of our QPs, and let us help you achieve excellence and maintain a competitive edge in the pharmaceutical industry. Contact us today to explore how we can support your company's success.

Good Distribution Practices (GDP) – Responsible Person (RP) ​ ​ To ensure the Good Distribution Practices (GDP) of your pharmaceutical activities, you rely on a Responsible Person (RP). When you partner with us, we will act as your designated RP, taking on the legal responsibilities mandated by the authorities. Our primary goal is to ensure that your wholesale distribution activities comply with GDP regulations and meet your public service obligations. We offer comprehensive services to support your company's compliance efforts. Our expertise includes implementing and maintaining a robust quality management system, managing authorized activities, ensuring accurate record-keeping, and coordinating recall operations when necessary. We also handle customer complaints, approve suppliers and customers, and oversee subcontracted activities impacting your activities. KS Pharma Services prioritizes continuous improvement and regulatory adherence. We conduct regular self-inspections, develop and deliver training programs for your team, and keep meticulous records of delegated duties. We are adept at making informed decisions regarding returned, rejected, recalled, or falsified products, as well as approving returns to saleable stock. Rest assured, we stay updated with the latest national laws and regulations, ensuring your compliance with any additional requirements specific to certain products. By entrusting us as your RP, you can focus on your core business activities with confidence, knowing that your wholesale distribution operations are in expert hands. Contact us today to discuss how we can tailor our services to meet your company's specific needs and help you achieve GDP compliance seamlessly.

KS Pharma BV

Terlicht 251

9450 Heldergem

+32 53 39 01 01

info@kspharma.eu

Contact us

Contact us

KS Pharma Bv

Terlicht 253

9450 Heldergem

bottom of page