Regulatory Support

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:

• National / international issues
• Centralised / decentralised / mutual recognition / National procedures
• Strategic support for new development concepts
• Communication with regulatory authorities
• Dossier creation and maintenance
• Pharmacovigilance
• Evaluation of regulatory documentation
• Literature research
• Support for non-clinical and clinical studies

Information

Information is the key to your success and PRSG keeps its clients up to date in all regulatory related issues through:

• Clients benefi t from PRSG’s monthly published newsletter and 1 hour consultancy services.
• The company offers internal and external training for regulatory affairs teams.

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.

• Dossier reformatting NTA -> CTD -> eCTD
• Evaluation of regulatory documents
• Product Information Update (SmPC, PIL, labelling)
• Monitoring deadlines

Applications

PRSG’s specialists guide customers through the complex regulatory world. It assists in the planning, submission, and maintenance of applications.

• Initial marketing authorisation applications, including full, generic or hybrid, bibliographic, informed consent, and variation
• Renewal applications
• Follow up activities
• Processing of deficiency letters
• Communication with regulatory authorities
• Support for non-clinical and clinical studies