BRINGING INNOVATIVE AND SAFE MEDICINAL PRODUCTS TO PATIENTS ACROSS THE GLOBE.
From ensuring that quality is built into the facility design, to the specification and monitoring of equipment and the training of client teams, our compliance experts have a detailed knowledge of good manufacturing practice guidelines and the latest in industry regulation.
This end-to-end experience ensures that strong quality management systems and operating procedures are in place, continually assuring the design, monitoring and control of a client’s manufacturing processes and facilities.
Responsible Persons
Our Responsible Persons (RP) ensure compliance with the Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) guidelines in the pharmaceutical manufacturing and distribution of medicinal products to guarantee the compliance with quality standards.
Ensuring compliance with quality standards in pharmaceutical manufacturing and distribution
The responsible person (RP) is a key figure in the pharmaceutical manufacturing and distribution of medicinal products. With extensive experience and in-depth knowledge of the Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) guidelines, the RP ensures compliance with all relevant regulations and standards.
Our RP services include:
Market release of pharmaceutical products: We ensure that all products manufactured and distributed meet the highest quality standards and comply with legal requirements.
Technical release and monitoring: Our RP teams are responsible for the technical release or decision on the non-release of product batches.
Audit and inspection preparation: We prepare your company for audits and inspections and support you throughout the entire process.
Supplier qualification: We audit and qualify your suppliers to ensure that all materials and products meet the required standards.
Quality management systems: introducing and maintaining robust quality management systems that ensure continuous monitoring and control of manufacturing processes and equipment.
Training and consultancy: we provide training and consultancy to ensure that your team is always up to date with the latest regulations and best practice.
Our RPs act as a vital link between our clients and the authorities. Clients can focus on their main business activities while we ensure compliance with all regulatory requirements. Our services are flexible and can be tailored to meet our clients’ specific needs, whether on an interim or mandate basis.
