SJR Associates is a medical device regulatory affairs, quality assurance, and clinical studies consulting firm. We specialize in point-of-care screening and diagnostic devices, and have experience with US FDA 510(k) submissions for Class I and II devices, with Canadian medical device licenses and submissions for Class I, Class II, and III devices, with European Union/CE marking requirements, and with Asia/Pacific Rim medical device registration/licensing requirements.Regulatory strategy (initial FDA contacts, pre-IDE submissions, predicate device research

Regulatory submissions: US FDA, EU, Canada, Rest of World (RoW)
Labeling development and/or review
Quality Systems/Compliance:
Quality System definition and implementation
Compliance audits
Compliance communications: Responses to 483s and Warning Letters, Field Actions (recalls, market withdrawals, field corrections), MDR/Adverse Event reporting
Training: develop training materials, coordinate/deliver employee training sessions
Develop/review/audit Design History Files, Technical Files, Design Dossiers
Testing coordination: Electrical safety, biocompatibility, shipping/packaging
Clinical protocol development and/or review
IRB submissions

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Bovard Consulting provides regulatory services to a variety of industries. We can provide comprehensive regulatory services or we can focus on specific projects, including assisting on an  as needed basis.

Medical Devices
General industry -- employee safety
Cosmetics
Over-the-counter Drugs

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Marion Weinreb & Associates, Inc. (MWA) is a dynamic consulting and staffing organization with expertise in GXP compliance. We ensure pharmaceutical, biotechnology, and medical device companies efficiently meet and exceed their compliance goals. MWA has demonstrated results in recommending and implementing successful solutions to address your compliance and staffing requirements! Our flexible staffing solutions provide you with value added options in addressing your strategic resource needs. In every case, we customize our services to the specific requirements of our clients to effectively achieve their goals. With our extensive recruiting capabilities and over 160 associates strategically located throughout the US, Canada, Europe, and India, MWA can assist you in meeting your regulatory goals in pre-clinical, development, or commercial operations. Our associates have an average of 15 years of experience in multiple disciplines relevant to your needs.

Analytical/Quality Control (QC) Support
Microbiology Support
Clinical and GCP Support
Packaging Engineering and Validation
CMC and Regulatory Affairs Support
Part 11 Compliance
Compliance Audits and Assessments
Pre-Approval (PAI) Auditing and Training
FDA Strategies
Project Management
Formulation Development
Quality Systems/QA Development and Support
GCP, GLP, GMP, ISO, and QSR Compliance
Risk Management and FMECA
Manufacturing Compliance Oversight
Technical and Document Writing
Manufacturing Engineering and Support
Training Programs: Standardized or Customized
Methods Development
Validation: Cleaning, Equipment, Process, Software
DDMAC: Promotional Advertising and Labeling Medical Affairs and Pharmacovigilance
Validation: Equipment and Software Vendor Management

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