OUR EXPERTISES
PPRS offers a broad range of services from early phase development support to clinical trial services and nonclinical consulting. Based on its expertise and experience as well as our broad network, PPRS assists small biotechs and larger biopharmaceutical companies at each step of the drug development process.
CMC
Early phase pharmaceutical development
- Formulations (chemical/physical properties testing and evaluations)
- Raw material selection and characterization
- Methods development and validation
Drug substance and drug product management
- Management and technical direction
- CMO selection and contracting
- Specifications and test methods
- Impurity profiling
- Manufacturing and release of clinical batches
- Packaging and labeling
- Distribution
CMC writing and submissions
- Technical Reports
- IMPD
- IND
Non-Clinical Development
Vendor selection, study execution and study management for:
- Vendor selection and study management
- Efficacy and safety pharmacology
- Pharmacodynamics and pharmacokinetics
- Proof of concept studies
- Mechanism of action studies
- Toxicology assessment
- Drug-drug interaction
- Drafting of regulatory documents
- Strategy design
Clinical Research
- Feasibility studies
- Study start-up including site identification, qualification and selection
- Third party vendor management
- Study document development
- Site monitoring and management
- Trainings
- Audit preparation
- IRB/EC submissions
- Regulatory: IB writing, CSR, CTA, IMPD, IND, NDA, orphan drug application
- Organisation of investigator meetings
Medical Device Innovative Solutions (MDIS)
Thanks to its team dedicated to the development of innovative medical devices, PPRS is able to offer solutions for the research and clinical fields. MDIS can also provide R&D, regulatory and business support to new actors.
Products & solutions
- Sleep scoring
– Polysomnography
– Somno-Art - Sleep diseases diagnostics
- Sleep questionnaire
- Sleep diseases therapies
Expertise
- Vigilance
- Circadian rhythms
- Signal analysis
Services
- Scientific expertise
- Software/hardware engineering
- Regulatory affairs (CE marking/FDA clearance)
- Market analysis
