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Italian company offers technical laboratory services and advisory for Life Sciences companies

Profile ID: 17887

Profile type: Business offer

Annotation

Italian non-clinical Contract Research Organization active in the field of specific laboratory services for in vitro and in vivo systems and regulatory support services is looking for foreign partners for services and subcontract agreement. The company, with decades experience as part of an international pharmaceutical firm, gained specific expertise in small molecules, biologics, oncology,clinical support areas. Activities in the medical devices and agrochemical fields are supported.

Offer description

Italian company providing technical services and scientific advisory in the field of Life Science is looking for international partners. The company is a non-clinical Contract Research Organization with more than 30 years experience serving international pharmaceutical and biotechnology companies, providing pre-clinical, biologics and small molecules services, acting as drug development partner. The company supports all stages of the drug discovery and development process, offering integrated services, including Attrition Reducing Technologies (ART) and toxicology screening for drug candidates. Other services offered are: investigating new drugs enabling packages; safety pharmacology; Developmental and Reproductive Toxicology (DART); PharmacoKinetics and PharmacoDynamics modelling; isotope chemistry/drug disposition; metabolite profiling and identification. The company gained a specific know how in developing oncology products, acting as an R&D site of major pharmaceutical companies and in collaboration with important clinical oncology centres in Europe and USA. The company also provides specific support services for clinical drug development programmes through: • Clinical Bioanalysis services: Immunoassay based methodologies, bioanalysis for Phase I Clinical Studies; facilities for light-sensitive and cytotoxic compounds, automated sample handling, biomarker assays, support for special studies; • Clinical Pharmacokinetic Analysis: bioequivalence studies, food effect studies; drug-drug interaction, Statistical assessment of dose proportionality, time-invariance and effect of genders, analysis and reporting of data pharmacokinetic data from Phase I/II Clinical trials; The company offers regulatory advisory services about drug safety, pharmacology safety, Absorption Distribution Metabolism and Excretion (ADME), and bio-analysis and pharmacokinetic studies to translate new chemical entities and bio-therapeutics into novel medicines. The firm also has a specific expertise in Medical Devices and Agrochemical fields. The company is looking for clients active in Life Sciences sector, with a specific focus on pharmaceutical, biotech and medical devices fields, which need laboratory services for in vitro and in vivo systems. The company will offer technical services upon clients’ request. The company is looking for long term international cooperation in the form of services and subcontracting agreement.

Innovations and advantages

The company collaborates with pharmaceutical and biotechnology companies based in European and Extra European countries managing pharmacokinetics, metabolism and toxicology issues. The company owns specific animal facilities, which accommodate rodent and non-rodent animal species, providing services packages and integrated studies to develop new therapeutics in all therapeutic areas. Moreover they can provide specific support services to develop New Chemical Entities (NCEs) and biologics as new oncology drugs. The company owns a specific analytical biology expertise focusing on bio-analysis and immunogenicity testing of different biological drug products, such as bioactive recombinant proteins/peptides, therapeutic monoclonal antibodies, as well as oligonucleotides and gene therapeutics, providing an extensive battery of state of the art technologies. All these services are performed and reported in accordance with Good Laboratory and Clinical Practice (GLP and GCP) guidelines and relevant international regulation (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - ICH, European Middle East and Africa – EMEA, Food and Drug Authority – FDA). The company constantly performs internal audit. Moreover, the company uses validated software services in accordance with the requirements stipulated by regulatory bodies. The company has a specific expertise in Medical Devices and Agrochemical fields.

Technology keywords

06001002 Clinical Research, Trials
06001003 Cytology, Cancerology, Oncology
06001012 Medical Research
06001015 Pharmaceutical Products / Drugs
06002010 Toxicology

Market application codes

04012 Toxicology
05001002 In-vitro diagnostics
05005014 Oncology
05005022 Other clinical medicine
05006 Anatomy, Pathology, Immunology, Physiology

Profile date

16.03.2019

Сотрудничество

Type of partner sought

Big and small companies active in the field of Life Science, with a specific focus on pharma, biotech and medical device sector, which need specific laboratory services and regulatory advisory. Cooperation type: Services Agreement and subcontracting.

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