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Company

Scottish Health Innovations

Street
206 St Vincent Street
ZIP Code
G2 5SG
City
Glasgow
Country
United Kingdom


Company Profile:
SHIL Regulatory Compliance Consultancy

SHIL offers consultancy specialising in regulatory compliance for product development and manufacture, combining Regulatory and Quality Management expertise.

Services include:

•Implementation of and monitoring quality assurance systems to ensure compliance with BS EN ISO 13485 for medical devices and EU Commission Directive 2003/94/EC covering GMP for medicinal products for human use and investigational medicinal products for human use. Experience covers UK MHRA and US FDA
•Auditing to GXP standards, covering manufacture, testing, distribution and clinical research
•Clinical development plans, management of clinical trial supplies and clinical monitoring
•Preparation and monitoring of project plans to develop medical devices and pharmaceutical products from inception through to regulatory submission and launch
•Regulatory strategies for product licensing and approval, US and Europe
Profiltitel

Regulatory and Quality Assurance Consultancy

What we offer:
Consultancy includes;
Implementation of and monitoring quality assurance systems to ensure compliance with BS EN ISO 13485 for medical devices and EU Commission Directive 2003/94/EC covering GMP for medicinal products for human use and investigational medicinal products for human use. Experience covers UK MHRA and US FDA
•Auditing to GXP standards, covering manufacture, testing, distribution and clinical research
•Clinical development plans, management of clinical trial supplies and clinical monitoring
•Preparation and monitoring of project plans to develop medical devices and pharmaceutical products from inception through to regulatory submission and launch
•Regulatory strategies for product licensing and approval, US and Europe

What are we looking for:
Looking for companies requiring external support .

Collaboration sought:
  • Commercial Agreement


Responsible

Sandy Allan

CEO
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Participants

Enterprise Europe ScotlandAboleo LtdAccuro BiologicsAlliance BootsBeta TechnologyBitWiseFW Medical LLPInnova Partnerships LtdInterface-The knowledge connection for businessMarks and Clerk LLPMcClure Naismith LLPThe Medical Device Company LtdQuantics Consulting LtdScottish Health InnovationsPharmalinksSistemic LtdStrathclyde Institute of Medical DevicesSynthetic Nanomachines LtdTissue SolutionsUniversity of AberdeenEllis IP LtdPharmacells LtdCeltic CatalystsPharmaceutical eConsultingWeatherologyControlled TherapeuticsSphere Fluidics LimitedHighland Clinical Research FacilityMoorfields PharmaceuticalsEdinburgh Science Trianglebeocarta LtdRostiShore DesignPomBioTech GmbHIMG Innovations-Management  GmbH/ Enterprise Europe NetworkThe Eurotactics ConsultancyIBA GmbHSGS Life Science ServicesOnorach  ClinicalWideblueEnterprise Europe YorkshireAptuit ConsultingMosaigen/Endeavour CapitalEscubed LtdEulysis Ltd.Raumedic LtdCatalent Pharma SolutionsEscubed LtdUniversity of Aberdeen Research and InnovationSPRI - Basque Enterprise Europe NetworkLicentia LtdTake The WindRoslin CellabMoredun ScientificEnterprise Europe East of EnglandAvantiCell ScienceXeroshield Ltd.ImmunoSolv LimitedLeoben Research LimitedPRAXI / HELP-FORWARD Network &The Hellenic BioClusterEMBIO Diagnostics Ltd


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