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RQMIS

Medical Devices, Pharmaceuticals, Nutraceuticals and Cosmetics Consulting Services

You can find us in the United States, European Union and United Kingdom

Barcelona, Spain (EU)

RQMIS opened our third location in Spain this past year to support our growing client base in the European Community as well as the European activities of our clients based outside the EU.

RQMIS is able to serve as the EU Authorized Representative (AR) for clients based in the US or UK who are looking to do business in the EU market. Clients will receive the same level of support that we offer in our other locations as well as access to in-country consultants on the ground in Spain.

London, England (UK)

Originally opened to support our clients doing business in the EU, RQMIS now has an office that is strategically located with the ability to assist our clients looking to sell their products in the UK post-Brexit.

RQMIS currently acts as UK Responsible Person for Medical Devices and Cosmetics. Our expert medical device consultants are ready to help our clients comply with new laws as they arise.

Services

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, and 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

NUTRACEUTICALS

  • General Consulting Services
  • FDA Compliance
  • Stability Data
  • cGMP Compliance
  • Supplier Qualification
  • Advice on Dietary Supplement Clinical Trials
  • Adverse Event Reporting
  • Dietary Supplement Label Review
  • Audits
  • Specification Development
  • Government Agency Representation (in the US and in the EU)
  • Regulatory, Safety, Risk, and Feasibility Assessments
  • GRAS Notification
  • NDI Notification
  • EFSA Notification

MEDICAL DEVICE

Regulatory

  • FDA 510k submissions / Denovo submissions
  • FDA Negotiations
  • Premarket Notifications (510(k)) – Including Notes to File (FDA)
  • Investigational Device Exemptions (IDE) and Supplements (FDA)
  • Premarket Approval Applications (PMA) and Supplements (FDA)
  • Labeling/Promotional Materials Review
  • FDA Registration and Listing
  • SBD
  • EU (MDD and MDR)
  • Competent Authority Negotiations
  • MHRA UKCA
  • MHRA UKRP
  • Clinical Evaluation Reports
  • Technical Files – Class I, IIa, IIb, and III
  • Design Dossiers – Active Implantables
  • Canada
  • 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
  • Internal Audits

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