Pharmaceutical and Regulatory Services
Pharmaceutical and Regulatory Services (PRSG) uses its vast experience, resources, and skills to provide individually-tailored...
Pharmaceutical and Regulatory Services (PRSG) provides complete regulatory work for a wide range of products.
The company comprises solutions for all issues concerning regulatory affairs for class 1 medical devices, food and nutrition, and cosmetics, as well as both human and veterinary medicinal products.
PRSG will support its clients across a product’s complete life-cycle, either by assisting or leading function for partial or complete marketing authorisation projects. Clients profit from the company’s experience in regulatory affairs for national/international projects and PRSG unites experience, creativity, flexibility, and high-quality work.
Client can benefit from PRSG’s experienced and qualified staff in all kinds of registration and authorisation projects. The company specialises in the creation of electronic submissions such as the preparation of chemistry, manufacturing, and controls (CMC) documentation. This meets the highest quality standards alongside professional and accurate life-cycle management.
PRSG’s young and dynamic team consists of pharmacists and biologists and it offers clients broad access to university knowledge in technical, pharmaceutical, or medical issues. The company’s expertise is your advantage.
Consulting
PRSG provides customers with professional, individual, and smart solutions for marketing authorisation projects. Clients profit from PRSG’s experience in the areas:
Information
Information is the key to your success and PRSG keeps its clients up to date in all regulatory related issues through:
Dossier creation
PRSG will create a dossier meeting national and international requirements and in accordance with legal demands.
The company can compile a complete dossier (modules one to five) or it can support the compilation of individual modules. PRSG revise, evaluate, and maintain all sorts of dossier-related documents and adapt them to distinct national requirements including eCTD, NeeS and vNeeS . PRSG can provide you with a wide variety of electronic submission formats.
Accurate life-cycle management and transparency of regulatory actions is of great importance for all areas of a pharmaceutical company. PRSG supports customers in the preparation of all kinds of variations, renewals, and periodic safety update reports.
Applications
PRSG’s specialists guide customers through the complex regulatory world. It assists in the planning, submission, and maintenance of applications.
Pharmaceutical and Regulatory Services (PRSG) uses its vast experience, resources, and skills to provide individually-tailored...