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Consulting Information Dossier Creation Dossier Maintenance Applications Regulatory Work from Start to Finish. www.prsg.at Medicinal Products Medical Devices Food & Nutrition Cosmetics Pharmaceutical and Regulatory Services GmbH provides complete regulatory work for a wide range of products in means of a One-Stop-Shop. We comprise solutions for all issues concerning regulatory affairs for medicinal products (Human / Veterinary), medical devices class 1, food and nutrition as well as 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. Profit from our experience in regulatory affairs for national and international projects. PRSG unites experience, creativity, flexibility and high quality work at one point! Medicinal Products (Human / Veterinary) Medical Devices (Class 1) Food & Nutrition Cosmetics & Wellness Pharmaceutical and Regulatory Services GmbH Mag. Lydia Langkammer Plüddemanngasse 104, A-8042 Graz Phone: +43 664 887 96964 offi[email protected] www.prsg.at Benefit from our experienced and qualified staff in all kinds of registration and authorisation projects. We are specialised in the creation of electronic submissions, preparation of CMC documentation that meets the highest quality standards as well as professional and accurate Life Cycle Management. Our young and dynamic team consists of pharmacists and biologists and we offer you broad access to university knowledge in technical, pharmaceutical or medical issues. Our expertise is your advantage! Spin off of
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Consulting Information Dossier Creation Dossier Maintenance Applications
Regulatory Work from Start to Finish.
www.prsg.at
Medicinal Products
Medical Devices
Food & Nutrition
Cosmetics
Pharmaceutical and Regulatory Services GmbH provides complete regulatory work for a wide range of products in means of a One-Stop-Shop.
We comprise solutions for all issues concerning regulatory affairs for medicinal products (Human / Veterinary), medical devices class 1, food and nutrition as well as 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.
Profit from our experience in regulatory affairs for national and international projects. PRSG unites experience, creativity, flexibility and high quality work at one point!
Medicinal Products(Human / Veterinary)
Medical Devices(Class 1)
Food & Nutrition
Cosmetics & Wellness
Pharmaceutical and Regulatory Services GmbH
Mag. Lydia Langkammer Plüddemanngasse 104, A-8042 Graz Phone: +43 664 887 96964 [email protected]
www.prsg.at
Benefit from our experienced and qualified staff in all kinds of registration and authorisation projects. We are specialised in the creation of electronic submissions, preparation of CMC documentation that meets the highest quality standards as well as professional and accurate Life Cycle Management. Our young and dynamic team consists of pharmacists and biologists and we offer you broad access to university knowledge in technical, pharmaceutical or medical issues.
Our expertise is your advantage!
Spin off of
PRSG simpli� es Regulatory Work!
ConsultingWe provide you with professional, individual and smart solutions for your marketing authorisation projects. Profi t from our 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
InformationInformation is the key to your success – PRSG keeps you up to date in all regulatory related issues.
• NewsletterBenefi t from our monthly published newsletter and 1 hour consultancy services.
• TrainingsWe off er internal and external trainings for your regulatory aff airs team.
Dossier CreationWe will create a dossier that meets all national and international requirements and is in accordance with all legal demands.
We can compile a complete dossier (modules 1 – 5) for your product or we can support you in compiling individual modules. We revise, evaluate and maintain all sort of dossier related documents and adapt them to distinct, national requirements.
eCTD, NeeS or vNeeS – We can provide you with any electronic submission format!
ü One-Stop-Shop ü High expertise ü Fast coverage of peak loads ü Individual and effi cient solutions ü Compliant marketing
authorisation dossiers ü Use of internationally established
electronic standards (eCTD) ü Expertise in new areas (Quality
by Design) ü Cost Control ü Access to experts in pharma-
ceutical engineering (RCPE)
Module 1: Not part of the CTD
Modules 2-5: CTD
RegionalAdministrative
Information
Non-ClinicalOverview
Non-ClinicalSummaries
Non-ClinicalStudy Reports
ClinicalStudy ReportsQuality
Quality Overall
Summary
ClinicalOverview
ClinicalStudy
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2
3 4 5
Dossier Modules provided by PRSG
Dossier MaintenanceAccurate Life Cycle Management and transparency of regulatory actions is of great importance for all areas of a pharmaceutical company. We support you in the preparation of all kinds of variations (Typ Ia/Ib/II), Renewals and Periodic Safety Update Reports.
• Dossier reformatting NTA -> CTD -> eCTD• Evaluation of regulatory documents• Product Information Update (SmPC, PIL, labeling)• Monitoring deadlines
ApplicationsPRSG’s specialists will guide you through the complex regulatory world. We assist you in the planning, submission and maintenance of your applications.
• Initial Marketing Authorisation Applications ü Full application ü Generic / Hybrid application ü Bibliographic application ü Informed consent application ü Variation Applications
• Renewal Applications• Follow up Activities• Processing of defi ciency letters • Communication with regulatory authorities• Support for Non-Clinical and Clinical Studies
