Produktentwicklung

• Entwicklung natürlicher Gesundheitsprodukte
• Produktentwicklung von A-Z
• Marktanalyse mit Evaluierung des Business Case und der Machbarkeit des Projektes
• Entwicklung von innovativen Produktkonzepten 
• Erstellung eines umfassenden Produktentwicklungsplans
• Scouting nach innovativen Inhaltsstoffen und Produkten 
• Bereitstellung eines umfassenden Partnernetzwerkes für die Entwicklung neuer Formulierungen
• Beratung zu möglichem Patentschutz
• Zulassung/Registrierung Ihres Produkts weltweit
• Marketing-Unterstützung vor und nach der Markteinführung
• Partner Finding für Business und Distribution

• Regulatory affairs services for drug development
  phases I – III
• Clinical Trial Authorisation (CTA) applications
• Orphan designations
• Pediatric Investigation Plan (PIP)
• Preparing of high quality regulatory documents
• Review of all scientific documents  (non-clinical, clinical)
• Answering CTA deficiency letters
• Lifecycle management (line extensions & indications extensions)

• Meet regulatory requirements
• Ensure adequate pre-clinical and clinical testing for the right product
• Differentiate between testing requirements, NCEs, line extensions, generics, new    indications, bibliographic applications

• Entwicklung von OTC-Innovationen beziehungsweise von Ideen für OTC-Produkte
• Trend-Scouting und Marktbeobachtung
• Erarbeitung von Alleinstellungsmerkmalen
• Marktscreening und Zulassungsrecherchen
• Konkrete Vorschläge für neue Produktideen
• Prüfung möglicher Rx-to-OTC-Switches und Line-Extensions
• Regulatorische und technische Machbarkeitsprüfungen
• Projektmanagement bis hin zur fertigen Entwicklung der OTC-Produkt-Innovation

ProPharma Group GmbH is a leading consultancy and project management organisation in the fields of (bio)pharmaceutical products, medical devices, and healthcare.

Contact us in any phase of your product's lifecycle if you are looking for a partner in Product Development, Regulatory Affairs, (Pharmaco)vigilance or QA/QC. 

•  CMC Program & Project Management
•  Investigational Medicinal Product Management
•  Up- & Downstream process development
• Scientific Writing
• Formulation Development
• Analytical Development
• Product release (QP)

ERA Consulting is a strategic regulatory consultancy for products such as vaccines, personalised medicine products, novel mAb's, biosimilars, complex proteins, cell and gene therapies, gene editing, regenerative medicine and NCE’s. ERA’s expert consultants are providing support ranging from strategic input, agency interactions, through to the management and writing of dossiers for marketing authorisation and electronic submission and interactions with various regulatory agencies such as EMA (including all National Agencies), FDA, PMDA, TGA, Health Canada and Swiss Medic. 

• Review and advice for product development
• Expert advice for development program
• Support for scientific advice meetings with regulatory agencies
• Applications for Orphan Drug Designation (EMA, FDA)

PharmaLex is a leading provider of specialized services for the pharma, biotech and medical device industries.

We guide you from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes and post-approval / maintenance post-launch activities. Our experts use technology enabled solutions to support you through the entire product lifecycle. We deliver exceptional results — going above and beyond the standard to deliver tailor-made solutions worldwide.

The PharmaLex Group now has over 1000 employees, with 33 offices in 21 countries and more than 600 satisfied clients worldwide.

• Beratung zu Entwicklungsstrategien
• Überprüfung und Vorbereitung von Berichten zur Produktentwicklung
• Beratungsgespräch mit der zuständigen Behörde
• Entwicklung von Formulierungen
• Programm und Projekt Management
• Management von Prüfpräparaten
• Wissenschaftliches Schreiben