GMP Scientific Inc.
Newtown, PA 18940
FDA Compliance Consultants
267.334.5722 (US)




Helping our Clients Build
Robust Quality System and
Sustainable FDA Compliance Program
with Cost Effective
and Customized Solutions.
 
Don't wait until its too late. Call us today!     (267) 334 5722

Services


We offer a broad range of Compliance and Quality System services for the Drugs, Biologics, and Medical Devices industry.
Our services are classified in the following specialty areas: Regulatory Compliance, Quality Systems Consulting, and Technical Services. As a supplement to these three areas, we also provide onsite training, and documentation services for our clients.
Regulatory Compliance:  We help our clients with FDA inspection preparation, post 483 and warning letter remediation, regulatory baseline audits, supplier quality management and recall related issues. We have developed well proven and targeted strategies to address the regulatory complexities.
Quality System Consulting: We help our client focus on the new 21st century risk based approach promoted and supported by the US FDA to help clients develop a well defined, robust, and sustainable processes that builds a strong Quality System.
Technical and Manufacturing Services: We provide expertise in the key areas of  Validations, including manufacturing Process Validation, Cleaning Validation, and Equipment Qualifications. We also support aseptic processes and Clean Room qualifications.
Training & Project Management: We provide onsite training for cGMP regulations and Root Cause Analysis. We also support Project Management for Quality and Compliance Initiatives.
Below are a few important FDA Links
FDA WEBSITE

21 CFR Part 210

21 CFR Part 211

FDA Warning Letters
FDA 483, Warning Letter, FDA Recall, 21 CFR 210, 21 CFR 211, Cleaning Validation, Process Validation, ISO 13485, 483 Remediation, Part 11 Compliance, Manufacturing Investigations, Medical Device Compliance, Injunction, Recall, Complaint Investigations, Adverse Event Reporting, MDR Reporting