Consultants for Good Distribution Practices (GDP)
OUR SERVICES FOR CLIENTS
Needs Analysis & GDP Consulting
Our tailored needs analysis and GDP consulting services are designed to ensure effortless adherence to Good Distribution Practice standards within the pharmaceutical industry. Through a comprehensive understanding of your specific requirements, we provide expert guidance to optimize your distribution processes and uphold regulatory compliance.
Quality Management Systems Development
With a focus on precision and efficiency, our team specializes in the development and updating of Quality Management Systems (QMS) tailored to your unique pharmaceutical operations. We partner with your team to implement robust systems that foster consistent quality assurance, regulatory compliance, and continuous improvement.
SOP & Site Master File Development
Our dedicated experts are proficient in the development and continuous updating of Standard Operating Procedures (SOPs) and Site Master Files, ensuring strict adherence to industry regulations and standards. We support you in establishing a solid foundation for effective quality management and regulatory compliance.
Self-Inspection Planning & Reporting
We plan and perform self-inspections in alignment with Good Distribution Practice guidelines. We provide comprehensive insights and actionable recommendations to enhance your internal quality assurance processes and ensure compliance with regulatory standards.
Supply-Chain Audit & Coordination
With a strong focus on supplier qualification and supply chain optimization, our supply-chain audit and coordination services are tailored to streamline your procurement processes. We conduct thorough audits and effective coordination to ensure the reliability and compliance of your supply chain, minimizing risks and ensuring product integrity.
Inspection Assistance & Action Plans
Our expert team provides comprehensive support during inspections conducted by competent authorities, facilitating a smooth and successful process. We assist in the development of post-inspection action plans, ensuring that your organization effectively addresses any identified gaps and implements necessary improvements to maintain regulatory compliance and operational efficiency.
Scientific Web Solutions
Tailored scientific web solutions service. We specialize in crafting customized websites for researchers and institutions. Our team understands your unique needs, ensuring your research gets the attention it deserves online. From user-friendly interfaces to seamless data visualization, we bring your scientific vision to life.
Get in touch
Ready to elevate your pharmaceutical operations? Reach out to us today!
Wholesale distribution authorization (WDA) and Responsible Person (RP) for wholesale#
Pharmaceutical companies and market authorization holders require a WDA. We support our clients in obtaining this license.
We can support by developing the necessary documents, updating and/or developing the quality assurance system (including SOPs). We are experienced in managing the licensing inspections by the Competent Authority.
We support our clients in complying with the requirements for obtaining a WDA within the meaning of Article 76 et seq. of EU Directive 2001/83/EC including:
- Pharmaceutical quality management in accordance with the EU GDP Guideline.
- Providing a person responsible for wholesale distribution (RP).
Sometimes, it is not economically feasible for a pharmaceutical company to employ a full-time employee as a RP for wholesale. We can act as the RP for wholesale distribution on a client’s behalf, for a short, interim, or longer period.
FOOD SUPPLEMENTS
Ideas, formulations, health claims
We support manufacturers of food supplements with our technical expertise in transferring an idea to a workable formulation and developing compliant associated health claims.
Marketability and Notification at Competent Authorities
Food supplements are subject to various EU and National regulations.
- We verify the compliance of the ingredients in product formulations.
- We ensure that food supplements meet the regulatory requirements.
- We support companies in determining the complete and correct labeling of their products.
- We support clients by notifying food supplements at the relevant Competent Authorities, on their behalf.
References
EU Directive 2002/46/EC: “Food supplements means foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities.”
EU Directive 2002/46/EC: Mandatory labelling of food supplements such as recommended daily intake and special considerations regarding children.
Regulation (EC) No. 1924/2006 and EU 432/2012: relevant health claims (advertising texts) for food supplements are subject to additional mandatory requirements.
Medical Devices
Person Responsible for Regulatory Compliance (PRRC)
According to Article 15 of the Medical Device Regulation (MDR) EU 2017/745, a PRRC is mandatory for every medical device manufacturer.
Micro- and small enterprises may subcontract a PRRC, who will be continuously and permanently at their disposal. We can provide PRRC services to our clients.
MDR compliant Technical Files
We can support our clients in developing MDR compliant Technical Documentation for their medical device products.