SERVICES
FDA/DUE DILIGENCE MOCK AUDIT
-
Facility Readiness / Pre-Approval and CMC Asessment
-
Biologics/Pharmaceuticals/Compounding Pharmacies 503A/B
-
Positron Emission Tomography
-
Over The Counter Drugs and Monographs
-
Combination Products
-
Medical Gas
-
Repackaging / Relabeling
-
Continuous Manufacturing / Process Analytical Technology
-
Postmarketing Adverse Drug Events
-
Microbiological and Chemistry Laboratory Audits
-
Active Pharmaceutical Ingredients
-
Data Integrity / Application Integrity
-
Dietary Supplements
STRATEGIC PLANNING
Think "Quality by Design" early on in your biopharmaceutical development ​
-
Facility Layout and Design
-
Equipment Selection
-
Research & Development Readiness to Support Scale Up
-
Phases 1, 2, and 3 CGMP Readiness
-
IT Infrastructure
TRAINING & COURSES
We provide the following types of training
-
Internal Audits using inspection software (ieQip)
-
CGMP Readiness
-
Pre-Approval Inspection Readiness
-
R&D to Scale Up
If you want training to think like regulators with software that cites like regulators, please reach out to us at info@wynngateconsulting.com for tailored training specific to your manufacturing operations and dosage forms.
COMPLIANCE
FDA's message is to be proactive rather than reactive to staying in compliance. Wynngate uses ieQip (www.ieqip.com) software to rate quality systems so you can proactively track your operations in real time. Contact us if you want need services in
-
Compliance
-
Compliance Case Development and Assessment
-
Compliance Strategies
Get a Quote
This is a Paragraph. Click on "Edit Text" or double click on the text box to start editing the content.