REACH UP srl offers assistance to pharma companies from the development of drugs and medical devices still their registration according the law. The presence of pharmacologically active substances should be limited to a level toxicologically considered safe for all those who will be exposed (operators / end users).
The protection of workers requires the determination of occupational exposure level (OEL) and the protection of enduser requires the derermination of the permitted daily exposure (PDE) (according GL: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/11/WC500177735.pdf). 


Our services about pharma include:

• Toxicological and pharmacological support and data gap analysis;
• Identification of the pharmacological toxicity and safety study and protocol design; assistance with laboratory selection, interpretation of study data, and review of study reports (GLP and non-GLP);
• Investigation of the mode of action and relevance to humans regarding toxicological effects;
• Assessment and qualification of toxicological risk for genotoxic and non-genotoxic impurities, (ICH Q3A, ICH Q3B and ICH M7) including nitrosamines; elemental impurities (ICH Q3D), solvents (ICH Q3C), extractables and leachables (E&L);
• Derivation of occupational exposure limits (OEL/OEB) and determination of Permissible Daily Exposure (PDE) Environmental Risk Assessment (ERA) of pharmaceutical products;
• Evaluation of the safety of excipients, permitted intake, calculation and determination of the safety margin;
• Integrated toxicology services using toxicological computation (Leadscope, Lhasa (Derek and Sarah) and others); (Q)SAR and read-across for various applications including regulatory ones observations (e.g. ICH M7);
• Non-clinical sections of IND/NDA; Due Diligence and data gap analysis Assistance with regulatory obligations;
• Review and/or revision of available toxicological data during the screening phase for new molecules and derivatives.

Our services about Medical Devices include:

• Biological Evaluation Plan and Biological Evaluation Report within a risk management process, in accordance with ISO 14971, 10993 and MDR;
• Clinical evaluation Plan and Report (CEP and CER) according to MDCG, MEDDEV and SSCP; 
• Gap analysis according to ISO standards and MDR;
• Justification for the classification of substance based MDs according to rule 21 of MDR;
• Pharmacological appraisal for functional ingredients: principal intended action by pharmacological, immunological or metabolic means, and rationale for the qualification of the product as a device; 
• Toxicological assessment of MD components according to ISO 10993 and MDR;
• Interpretation of results obtained in biocompatibility assessments in accordance with ISO 10993-1; 
• Toxicological Risk Assessment of extractables and leachables according to ISO 10993-17;
• Regulatory compliance.

This expertise is available to issue specific customer requirements and our team work judgement will offer the best available solutions.