Services
For product development
Product engineering
Isolation and identification of microorganisms and/or extraction of metabolites and peptides
Discovery: In vitro / in vivo (e.g. MIC and synergism evaluation with the identification the LD90 against the pathogens).
Formulation development considering the intrinsic properties of the main actives
Pilot production: upstream (e.g. fermentation and plant extraction) and downstream (e.g. concentration of the fermentation broth and purification process)
Industrial scale-up: upstream, downstream and formulation steps
Services
For registration (consultancy services)
According to the 1107/2009 and the data requirements EU no. 283/2013 and 284/2013
Data Gap Analysis (eventual preliminary Risk Assessment) and Regulatory Strategy
Dossier preparation (MA + MP) following the specific guidance
- SANCO/12545/2014 rev 2 (Microbial Agents)
- SANCO/12815/2014 rev 5.2 (Semiochemicals)
- SANCO/11470/2012 rev 8 (Botanicals - plant extract)
Biological Assessment Dossier (BAD) preparation
Risk Assessment for humans and environmental
National applications in the EU countries
Scientific support and study monitoring
Meetings with Authorities and Contract Institutes
Additionally, KISAR BIOSOLUTIONS can contract, design and/or monitor studies for dossier preparation. Adaptations on study design can be provided by our expert group and study directors in the different dossier sections.
Depending on the study type it is possible to decide whether GLP, GEP or usual laboratory conditions are required.
Services
For EU registration (supporting activities)
Microbial analysis (whole genome sequence analysis (WGS), metabolites and toxins screening, minimum inhibitory concentration (MIC) determination for antibiotics and other anti-microbial agents, 5-batch analysis under GLP conditions)
Physico-chemical properties of the preparation (storage stability, shelf-life, technical characteristics, compatibility aspects)
Efficacy data package according to the GAP table under GEP conditions (including preliminary tests, efficacy trials, resistance information, effects on quality and quantity, phytotoxicity, adverse effects, observations on undesirable or unintended crops)
Effects on Human Health – basic studies under GLP conditions (acute toxicity, pathogenicity and infectiveness), if relevant genotoxicity, cell culture and short-term toxicity studies
Residues on treated products – statements and spore decline curve
Environmental fate – initial PEDs calculations, microbial persistent studies
Non target organism studies on aquatics and terrestrials organisms
