Jack Sinclair
Qa Ra & Clinical Collaborator at Rrxco
Based in London, United Kingdom
7-day free trial · no credit card
Seniority
Other
Department
Other
Location
London
Industry
Biotechnology Research
Company size
12
Contact information
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j•••••••@rrxco.com
Phone
5 credits+44 ••• •••• ••••
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Background
About Jack Sinclair
A Business Manager at RRxCo, with a background in the Medical Device and PharmaBio space. A strong expertise in the generation of business portfolios within MedTech, Pharmaceuticals. Our MedTech services include- EU MDR & IVDR Technical Documentation Authoring - FDA Regulatory submissions; 510(k), De Novo, PMA - CER, PER & PMCF Authoring - Regulatory Strategy - ISO 13485 QMS development and maintenance - Global Audits with local experts Our PharmBio Services include- QMS Implementation & Development, Quality Harmonisation & Training (GxP), GAP Analysis - Mock & Pre-Approval Inspection, Remediation, Risk Management & Assessment - Submissions & Applications (IND, NDA, ODD & BLA), Regulatory CMC - Authority Meetings (MHRA, EMA, FDA), Pathway Development & Reviews - Clinical Development, Clinical Programme & Project Management - Clinical Operations (Site Management, Feasibility & Study Start-Up) PharmaBio Auditing Capabilities- Drug Product/Drug Substance - Excipients/Raw Materials & Consumables - Contract Research Organisations & Clinical Investigator Sites - Trial Master Files (TMF) & Good Clinical Laboratory Practice (GCLP)- Nonclinical Laboratories and Pre-Clinical Services - Warehouse/Distribution Centres - CSV, Data Integrity & Ancillary Services (Software, Pest Control, etc.) Contact Details: Email: jack@rrxco.com Phone:+447788260835
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