PRSG Services

PRSG Services

- Comprehensive support.

 
Consulting
Information
Services
Dossier
Creation
Dossier
Maintenance
Applications
   

Regulatory Affairs is an area of rapid change and ever increasing demands. Companies in the healthcare sector need to work smarter than ever before, especially in the global arena. Regulatory cooperation is a key strategy that can help Pharmaceutical, Biotechnology, Medical Device and Nutraceutical companies to focus on their core competencies and innovations.


PRSG offers a comprehensive portfolio of regulatory services, which comprises of best practices and solutions for:
      Medicinal products (human / veterinary)
     Radiopharmaceuticals
     Medical devices class 1
     Cosmetics
     Nutritional and dietary supplements
     Foods for special medical purposes
     Wellness products

Maintaining a large regulatory affairs department can be very expensive and scope of knowledge can be limited to certain aspects. In our company we unite expertise, high qualification, detailed knowledge as well as flexibility and highly motivated staff. Due to our broad range of projects we are used to become acquainted with new tasks and responsibilities extremely fast which shortens the usual training period significantly in comparison to new employees. Clients will benefit from the first day of the cooperation as our staff can be appointed to various areas within a regulatory affairs department.

We offer tailored services and provide high service orientation while delivering work on time and in high quality. PRSG's team is known for professionalism and individual solutions for complex problems. Our objective is to establish satisfying long-term cooperations with our partners and to be a competent partner for Drug Regulatory Affairs.

   

 

Options for cooperation

Regulatory affairs projects can be supported either in assisting or leading function for partial or complete marketing authorisation projects.

Outsourcing can be offered in two main categories:
    Short-term / project based cooperation
    Long-term cooperation.

Which cooperation fits your company best depends on the requirements of the ongoing or planned project. Short-term / project based outsourcing may be interesting for companies that need to cover peak loads in case of a temporarily large volume of projects and shortage of qualified personnel. Long-term outsourcing leads to a long-term cooperation between the partners which gives the customer the possibility to focus on his core competencies and to pursue the business strategy.

Benefits of a partnership include a decrease of fix costs of human resources, time-saving as well as the access to qualified staff with broad expertise.

Our experts for Regulatory Affairs will guide you safely through the numerous and varied national and international procedures.

 

Key benefits

    One-Stop-Shop for RA issues
    High expertise
    Fast coverage during peak loads
    Target-oriented advice
    Individual and efficient solutions
    Compliant dossier in CTDformat
    Established electronic standards
    eCTD / NeeS
    Cost control
    Experts in engineering (RCPE)