BiQ Pharma

– Your partner from Development to Market

BiQpharma1• Built in Quality in project planning & execution
• Analytical services
• Design of preclinical and clinical PK/PD studies
• Planning and conducting stability studies, following current ICH guidelines
• GMP certified by the Swedish Medical Product Agency

 

REGULATORY MANAGEMENT
CTD, ICH, GLP, GMP, GCP, GDP and  ISO – guidelines

OUR BUSINESS AREAS :

Project Management
• Setting project objectives/project plans
• Work in cross functional groups
• Evaluate project progress by milestone reviews
• Selecting partners/suppliers

Supply of pharma product candidates to preclinical and clinical trials
• Process and product development
• Manufacturing of drug product candidates
• GMP- certified by Swedish Medical Product Agency to  packaging and release for clinical use

Design of Preclinical Studies – PK & PD
• Perform hands-on PK, PK/PD and TK modeling exploring in vitro/in vivo data
• Design, compile and report in vivo studies (e.g. effect, toxicity and safety studies)
• Simulate PK/PD profiles including early dose in man

Pharmaceutical Microbiology
• Clean room & aseptic process assessment, environmental control, Micro QC lab services, Rapid Microbiology

Pharmaceutical GMP certified Chemical and Biochemical Analyses
• In accordance with GLP/GCP/GMP/GDP /ICH and ISO-guidelines

Stability studies
• Planning, execution  and report of stability program
• Storage and continuous monitoring of environment (temperature and humidity) of Biological samples following International standards

Regulatory, QA/QC management  
• Plan and design Regulatory documentation in accordance with CTD, ICH, GMP, GCP, GDP
• Development/improvement of quality systems
• Conduct audits

Contacts:  Christer Johansson +46 (0) 702 068 233 christer@biqpharma.com
Ulf Appelgren +46 (0) 704 040 700 ulf@biqpharma.com

Forskargatan 20 J, SE-151 36 Södertälje
+46 (0)8 210 016
http://www.biqpharma.com