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- sales@fdaiso.com
We respond to most inquiries within 24 hours
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About us
We are a team of scientists and engineers with over 40 years of combined US/International regulatory experience and GMP implementation programs. We provide robust and effective product design and validation solutions to ensure parallel track with strategic business goals. We can assist with: designing, developing, manufacturing and distributing systems for complying with FDA - QSR, ISO 13485, ISO 9001, Medical Device Directive (MDD), and CE Marking. Industries include Medical Device Manufacturers, Pharmaceutical and Nutraceutical Companies, and Biotechnology and Advanced Therapeutics.
Regulatory and GMP Consulting Services
We have expert capabilities in the areas:
- PMA/510k submissions – General Hospital and Surgery Devices, Orthopedic Devices and In Vitro Diagnostics.
- NDA/ANDA submissions – LVP's, SVP's, and solid dosage forms.
- Design and develop comprehensive Quality Management Systems.
- Compliance audits for FDA-QSR, ISO 13485, ISO 9001, Medical Device Directive (MDD), and CE Marking.
- Sterilization Validations: ETO, STEAM, GAMMA.
- Product/ Packaging Design and Validation.
- Scientific soundness of finished product test methods.
- Product shelf life (Real-Time and Accelerated Aging).
- Equipment/Instrument design, validation and calibration.
- Product trend analyses, failure analyses and risks analyses.
- Clean Rooms and Environmentally-Controlled Rooms: Class 100, 1000, 10,000 and 100,000.
- Aseptic processing; ECR attire, operations and processing.
- Statistical sampling schedules, sample preparation techniques and quantitative and qualitative testing.