Pharmaceutical Product Development
Find service providers in the field of pharmaceutical development e.g. for the development of new drug substances or finished products and the set-up of development plans.
The list does not claim to be complete and there can be no guarantee for the correctness and timeliness of the information provided. Furthermore, please note that this list does not have any
recommendatory character.
If you are a service provider in this area, you have the possibility to register free of charge in this directory.
- Product development from A to Z
- Market analysis including the evaluation of business case, project feasibility and development of a business plan
- Development of innovative product concepts
- Establishment of comprehensive product development plan
- Scouting for innovative ingredients and products
- Providing a comprehensive partner network for the development of new formulations
- Strategic consulting on patent protection possibilities
- Execution of notification or registration process of your product
- Pre- and post-launch marketing support
- Distributor and business partner finding
Michor Consulting and Trade Services GmbH
Schönbrunnerstrasse 238/2/6
1120 Wien
Austria
office@michor-consulting.eu
- 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
- Development of OTC innovations or OTC product ideas
- Trend scouting and market surveillance
- Development of key differentiators
- Market screening and marketing authorisation research
- Specific suggestions for new product ideas
- Evaluation of potential Rx-to-OTC switches and line extensions
- Regulatory and technical feasibility assessments
- Project management through to the finished development of the OTC product innovation
- Guidance on development strategy
- Expert advice during development
- Review & preparation of product development reports
- Compliance check with EU, FDA & other global filing strategy
- Scientific advice meetings with agencies
- Formulation Development
- Scale up and manufacturing technology transfer services
ProPharma Group GmbH
Siemensdamm 62
13627 Berlin
Telefon: 030/856 06878-0
regulatory.de@xendo.com
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)
During development, our clients face many challenges. The Pharmexon team is able to perform ongoing due diligence, as well as offer on-site support (if required) in order to assist in continued successful development. Additionally we are able to advise and support the appropriate strategy to begin and/or continue dialogue with Agency experts as part of a Scientific Advice program. Our experts are able to review a development from the perspective of regulators, and the wider network is able to provide inputs into practical elements of a development. Additionally, our team can provide advice on leveraging data being generated for a specific region and how a program can be truncated for another region.
Some of the services offered in this area are:
- Due Diligence of CMC data during formulation development and scale-up
- Due Diligence of Synopsis/protocol and reports of preclinical and clinical program
- Ongoing support of development processes, analytical methods,raw material qualification, process controls
- Review of preclinical data in order to present clinical program to regulators
- Preparation and review of PK data for standard/complex generics
- Preparation of Briefing Books including Question placement, data presentation, face- to-face representation and extrapolation of outcomes
- On-site support and monitoring of clinical/nonclinical studies
- Clinical trial applications - preparation and support
- Critical support, reviews and data use between EU and US
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.
- Guidance on development strategy
- Review & preparation of product development reports
- Scientific advice meetings with agencies
- Formulation Development
- Program & Project Management
- Investigational Medicinal Product Management
- Scientific Writing