Consulting

Consulting

Strategic support and solutions for various regulatory issues.

 

Well-founded knowledge in the area of regulatory affairs has to be based on knowledge of relevant regulations, directives, national law as well as guidelines and experience gained from the work with authorities. The PRSG team is highly skilled and trained to carry out all kinds of regulatory work. The regular attendance of specific trainings and the high interest on current topics distinguish our personnel and results in detailed actual knowledge in the regulatory affairs area.
PRSG assists in the evaluation and preparation of marketing authorisation dossiers for new or existing healthcare products, generally based on existing documentation. We support in Life Cycle Management and offer assistance concerning quality related issues, specialised update and revision of product informations as well as in the choice of the appropriate regulatory strategy.

PRSG offers professional, individual and smart solutions for your registration and authorisation projects.

Expertise in the following areas

Strategic and regulatory advice for national / international Issues
Strategy formation for new development concepts, partly
     in cooperation with RCPE
Choice of appropriate application procedures
Evaluation of regulatory or CMC documentation
Compilation of a complete MA dossier
Regulatory and commercial compliance   
     - Life Cycle Management (Variations, Renewal procedures,...)
     - Product Quality Reviews
Quality management
Preparation and attendance at meetings with authorities
    (pre-submission meetings, scientific advice)
Support in the area of CE-Certification
Health claims
Pharmacovigilance assistance
Non-Clinical & Clinical Studies
Application for SME status
Application for Scientific Advice related to Quality, Non-Clinic or Clinic

 

 

"PRSG meets expectations in terms of high quality work on dossiers and agreed timelines. So for us PRSG team is the first choice when regulatory support is needed."

Mag. Hildegund Erhardt
Fresenius Kabi Austria

 

        EXPERIENCE

Experience in pharmaceutical industry is an essential factor for pharmaceutical regulatory consultants. We set great value upon the qualification and educational background of our personnel. We are experienced in strategic planning and implementation of regulatory concepts as well as in the preparation and submission of regulatory documents.

 

 

        RESOURCES

We have a team of 4 employees and / or can collaborate with other service providers (e.g. medical doctors, pharmacologists,...) to serve ongoing projects without delay.The PRSG team can cover peak loads in regulatory affairs departments. Due to their versatility our regulatory affairs managers can be appointed to all kind of projects.

 

 

        SKILLS

The involved staff is highly skilled and trained to carry out regulatory work. Our team attends further trainings regularly and sets high priority on current topics in regulatory affairs. PRSG’s personnel keep on updating themselves with current regulations and have vital experience in the field of new applications and maintenance of marketing authorisation dossiers.

 

 

        INDIVIDUAL
        SOLUTIONS

All services are customised and available on a modular basis meeting the specific requirements of our clients. We will work out the right strategy for your product, taking into consideration all relevant parameters, including internal company timelines, business plans and budget as well as planned marketing goals and launch dates.

 

 

        INFORMATION
        TECHNOLOGY

We work with highest technological standards and keep our systems updated consistently. PRSG can provide all kind of electronic submissions, using the docubridge® software of the Lorenz Life Sciences Group.