RCPE's spin off - Regulatory services and submissions

1. Pharmaceutical and Regulatory
Services GmbH provides complete
Regulatory
regulatory work for a wide range of
products in means of a One-Stop-Shop.
Work
We comprise solutions for all issues from Start to Finish.
concerning regulatory affairs for
medicinal products (Human /
Veterinary), medical devices class 1, Benefit from our experienced and qualified staff
food and nutrition as well as cosmetics. in all kinds of registration and authorisation
projects. We are specialised in the creation of
electronic submissions, preparation of CMC
Medicinal Products documentation that meets the highest quality
standards as well as professional and accurate
(Human / Veterinary) Life Cycle Management. Our young and dynamic
team consists of pharmacists and biologists and
Medical Devices we offer you broad access to university knowledge Medicinal
(Class 1) in technical, pharmaceutical or medical issues. Products
Our expertise is your advantage! Medical
Food & Nutrition Devices
Food &
Cosmetics & Wellness Nutrition
Cosmetics
We will support you across a product’s
complete life cycle, either in assisting or
leading function for partial or complete
marketing authorisation projects. Consulting
Pharmaceutical and Regulatory
Profit from our experience in regulatory Services GmbH Information
affairs for national and international Mag. Lydia Langkammer Dossier Creation
Plüddemanngasse 104, A-8042 Graz
projects. PRSG unites experience, Phone: +43 664 887 96964 Dossier Maintenance
creativity, flexibility and high quality office@prsg.at
Applications
work at one point! www.prsg.at Spin off of
www.prsg.at

2. Consulting Dossier Maintenance
PRSG simplifies We provide you with professional, individual and Accurate Life Cycle Management and transparency of
Regulatory Work!
smart solutions for your marketing authorisation regulatory actions is of great importance for all areas
projects. Profit from our experience in the areas: of a pharmaceutical company. We support you in the
preparation of all kinds of variations (Typ Ia/Ib/II),
• National / International Issues Renewals and Periodic Safety Update Reports.
• Centralised / Decentralised / Mutual Recognition /
National Procedures • Dossier reformatting NTA -> CTD -> eCTD
• Strategic support for new development concepts • Evaluation of regulatory documents
• Communication with regulatory authorities • Product Information Update (SmPC, PIL, labeling)
• Dossier creation and maintenance • Monitoring deadlines
• Pharmacovigilance
• Evaluation of regulatory documentation
• Literature Research
Dossier Modules 1 Module 1:
Not part of the CTD
• Support for Non-Clinical and Clinical Studies
provided by Regional
Administrative
PRSG Information
Information 2 Non-Clinical
Overview
Clinical
Overview
Information is the key to your success – PRSG keeps Modules 2-5:
you up to date in all regulatory related issues.
Quality
Overall Non-Clinical Clinical
CTD
Summary Summaries Study
• Newsletter
Benefit from our monthly published newsletter
and 1 hour consultancy services. 3 Quality 4 Non-Clinical 5 ClinicalReports
Study Reports Study
• Trainings
ü One-Stop-Shop We offer internal and external trainings for your
ü High expertise regulatory affairs team.
Applications
PRSG’s specialists will guide you through the complex
ü Fast coverage of peak loads
Dossier Creation regulatory world. We assist you in the planning,
ü Individual and efficient solutions submission and maintenance of your applications.
We will create a dossier that meets all national and
ü Compliant marketing international requirements and is in accordance with • Initial Marketing Authorisation Applications
authorisation dossiers all legal demands. ü Full application
ü Use of internationally established ü Generic / Hybrid application
We can compile a complete dossier (modules 1 – 5)
ü Bibliographic application
electronic standards (eCTD) for your product or we can support you in compiling
ü Informed consent application
ü Expertise in new areas (Quality individual modules. We revise, evaluate and maintain
ü Variation Applications
all sort of dossier related documents and adapt them
by Design) • Renewal Applications
to distinct, national requirements.
• Follow up Activities
ü Cost Control
eCTD, NeeS or vNeeS – We can provide you with any • Processing of deficiency letters
ü Access to experts in pharma- electronic submission format! • Communication with regulatory authorities
ceutical engineering (RCPE) • Support for Non-Clinical and Clinical Studies