Doing or planning to do business outside of the US? Visit our sister companies. RQMIS AR LTD. or RQMIS EU SL More

RQMIS in Spain and the United Kingdom

Barcelona, Spain


RQMIS is located in the EU (both pre and post BREXIT) to support our growing client base in the European Community and the European activities of our non-EU clients based throughout the world. Our clients receive in depth regulatory strategy/submissions, quality systems design/compliance and clinical study design/management support as well as our ongoing EU Authorized Representative services.

London, UK

The synergy among all of the RQMIS companies is fundamental for the development of business and projects. RQMIS companies are interconnected, and the professionals works together to achieve the best results. This is the big key for all companies wanting to do international business. RQMIS can provide the following EU based services to support our EU and non-EU based clients.

PHARMACEUTICAL

Pharma services (generic / new drugs /biologics)

  • Authority communications
  • Submission
  • Licensing UE (Centralized also)
  • Grandfathering & UK baseline (due to Brexit)
  • Variations
  • Life cycle
  • Audits

Pharma Dossier Preparations, Submission and Approval

  • Dossier writing (CMC & medical writing) for CTD, aCTD, eCTD, Special formats
  • Consulting for M1 writing
  • Updates
  • Consulting for New markets requirements
  • Global Regulatory Strategy

CMC

  • Batch disposition and deviation resolution
  • Biopharma CMC
  • Validations strategies (Product & Cleaning)

Quality

  • Classification of Changes
  • PSUR (Periodic Safety Update Reports)/ PBRER (Periodic Benefit-Risk Evaluation Report)
  • SOP´s
  • Quality manuals

DIETARY SUPPLEMENTS

  • General Consulting Services
  • FDA product compliance
  • Stability Data
  • Health Claim Substantiation Assessment and Product Development
  • cGMP Compliance
  • Supplier Qualification
  • Advice on Dietary Supplement Clinical Trials
  • Adverse Event Reporting
  • Dietary Supplement Label Review
  • Litigation and Defense Research
  • Expert Witnessing
  • Specification Development
  • Government Agency Representation (in US and in EU)
  • Regulatory, Safety, Risk, and Feasibility Assessments
  • GRAS Notification
  • NDI Notification
  • EFSA Notification

MEDICAL DEVICE

Regulatory

  • United States
  • FDA Negotiations
  • Premarket Notifications (510(k)) – Including Notes to File
  • Investigational Device Exemptions (IDE) and Supplements
  • Premarket Approval Applications (PMA) and Supplements
  • Labeling/Promotional Materials Review
  • Registration and Listing
  • EU (MDD and MDR)
  • Competent Authority Negotiations
  • Clinical Evaluation Reports
  • Technical Files – Class I, IIa, IIb and III
  • Design Dossiers – Active Implantables
  • Canada
  • Device Licences
  • Rest of World
  • Premarket Submissions

Quality

  • ISO 13485 Quality System Design/Compliance/Auditing
  • FDA QSR and Human Tissue GMP Design/Compliance/Auditing
  • Managed several Level I and Level II QSR audits (in US and Japan) and Human Tissue
  • FDA Negotiations/Responses to 483’s, Warning Letters and Recalls
  • Managed Recall/Complaint Handling/Vigilance Reporting/MDR Process

Clinical

  • Overall Clinical Study Management – phase II, III and Post Marketing Surveillance/PMCF
  • Protocol design/development
  • Case Report Form design/development
  • Insurance Reimbursement
  • Bioresearch Monitoring
  • Managed FDA Sponsor Bioresearch Monitoring Visits
  • Assisted Clinical Study sites with FDA Bioresearch Monitoring Visits

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