BioProof - Bioanalytics, Non-Clinical and Phase I Study Management, Pk-Evaluation, Medical Writing Services, Regulatory Support and Development Consulting

BioProof is a private German contract R&D service company based in Munich. We are dedicated to the pharmaceutical development of small molecule drugs as well as 'biologicals' from the non-clinical through early clinical phases. BioProof is a GLP certified bioanalytical laboratory with rapidly growing international reputation for method development, validation and quantitative measurement of parent molecules or biotransformation products in different types of biological matrices (blood, plasma, serum, urine, bile, tissues, etc, from PK studies in man and animals, including toxicokinetics).

BioProof is a team of fully trained, dynamic and flexible professionals. About half of the staff is graduated from universities in biology, chemistry and pharmacy. Our management team members have between ten and 25 years experience in international development in pharmaceutical industry. BioProof's focus is to work registration oriented in close collaboration with our clients and with a clear understanding of the complete process from the early development to the clinical proof-of-concept stage.

BIOANALYTICAL SERVICES-ANALYTICS OF SMALL MOLECULES

The equipment includes:

• Micromass Quattro LC
• Micromass Quattro Ultima
• Waters Quattro Ultima Pt
• Several HPLC with UV/VIS, fluorescence and electrochemical detection
• Anthos Lucy 1, Spectramax 340PC and Wallac Victor² ELISA automates
• 96-well solid phase extraction
• Cell culture facilities

This equipment allows for analytics of small molecules as well as peptide and protein type biologicals and biomarkers.

NON-CLINICAL AND CLINICAL STUDIES

From the industrial background we are experienced to manage non-clinical and clinical PK studies with our network partners who bring their specific expertise into the in-life phase.

Non-clinical ADME studies inckude:

• Toxicokinetic studies
• Human bioavailability and bioequivalence studies
• Special populations, e.g. elderly, renal or hepatic impairment

Pharmacokinetic and biostatistic evaluations are performed using WinNonlin (or Kinetica) and the data can be interpreted together with our clients with respect to the whole development scenario.

MEDICAL WRITING, CLINICAL TRIAL REPORTS AND REGISTRATION SUPPORT

We write your non-clinical ADME reports or pharmacokinetic-based integrated clinical trial reports and investigator's brochures according to GCP. Complete IMPDs (Investigational Medical Product Dossiers) according to the new clinical directive and registration dossier parts in CTD format can be compiled as well.

CUSTOMER SERVICE AND PHARMACEUTICAL PROJECT MANAGEMENT

The different academic backgrounds and the experience of our team in project management in the pharmaceutical industry as well as the stimulating contract work formed a broad knowledge base for development consulting especially at the intersections between CMC, non-clinical ADME and toxicology and early clinical stages. This can be backed-up and complemented by our network partners.

QUALITY, SPEED AND EFFICIENCY

We are proud of the skills and dedication of our staff and the people pay back, because they really like the work they are doing. We continuously invest in our staff and equipment to offer high-end solutions for the challenges of your compounds under development. We adhere to the current guidelines and strictest quality controls to achieve the most relevant results at the fastest speed possible. Relevant results are made available to the client during the project process for interim analysis and risk evaluation. As a lean company we have low overhead costs and more than 80% of our staff can work directly for your projects-you pay for performance, not for bureaucracy.

ANALYTICAL AND PHARMACOKINETIC EXPERIENCE

If you look for a CRO with broad analytical and pharmacokinetic experience in the non-clinical and clinical area, that ensures excellent communication with their clients, consider BioProof for the discussion or your needs and preparation of a quote and timeframe for the results you require. We offer you the option where high quality work, integrity and flexibility are combined in a cost effective manner.