Your Quality and Compliance Partner!
To navigate through complex regulations, and to sustain regulatory compliance with modern GMPs, you need experienced, cost-efficient, and reliable partners. We offer the following high value, comprehensive FDA Consultancy Services to our clients:
FDA Readiness & Response
- Prepare for an FDA Inspection (PAI/Post Approval GMP/For Cause)
- Respond to FDA findings and Warning Letters
- Develop CAPA
![](https://gmpscientific.com/wp-content/uploads/2024/11/FDA-Readiness-AdobeStock_31042336-1024x645.jpeg)
![](https://gmpscientific.com/wp-content/uploads/2018/05/A_GMP_QM_Optimized-1-1-1024x614.jpg)
Quality Management Services
- Develop or Revise your Standard Operating Procedures (SOP)
- Develop Effective CAPA program
- Support Batch Record Reviews
- Establish Quality Metrics Program
- Manage Deviations and Investigations
- Prepare Annual Product Reviews (APR)
Assessments & Audits
- Conduct Self-assessment and internal audits
- Perform Suppler Audits/Qualifications
- Develop Quality Agreements
- Conduct Data Integrity Assessment
![](https://gmpscientific.com/wp-content/uploads/2024/11/Assessment-Audits_AdobeStock_49725046-1024x739.jpeg)
![](https://gmpscientific.com/wp-content/uploads/2024/11/Continmuous-Improvement-AdobeStock_94355258-2023_01_17-20_15_35-UTC-1024x684.jpeg)
Continuous Improvement Projects
- Support Process Validation and Process capability projects
- Support Lean and six-sigma projects
GMP Training – Learning & Development
- Develop Customized Training Program
- Develop Self Learning Modules for your LMS
![A man, known as an FDA Consultant, smiles and points at a flipchart during a meeting in a bright office. Four colleagues sit around the table, attentively listening and holding documents.](https://gmpscientific.com/wp-content/uploads/2024/11/Training-AdobeStock_110411635-1024x683.jpeg)
Why Choose Us
With so many consultants to choose from, we stand out by delivering professional project management, ethical execution, and process excellence. We ensure clear objectives, qualified resources, and transparent financial practices, all backed by a commitment to integrity. Our lean processes and client-focused approach drive optimal results every step of the way.
FAQ
A frequently asked question surrounding your service
A detailed answer to provide information about your business, build trust with potential clients, and help convince the visitor that you are a good fit for them.
A frequently asked question surrounding your service
A detailed answer to provide information about your business, build trust with potential clients, and help convince the visitor that you are a good fit for them.
A frequently asked question surrounding your service
A detailed answer to provide information about your business, build trust with potential clients, and help convince the visitor that you are a good fit for them.
A frequently asked question surrounding your service
A detailed answer to provide information about your business, build trust with potential clients, and help convince the visitor that you are a good fit for them.
A frequently asked question surrounding your service
A detailed answer to provide information about your business, build trust with potential clients, and help convince the visitor that you are a good fit for them.
A frequently asked question surrounding your service
A detailed answer to provide information about your business, build trust with potential clients, and help convince the visitor that you are a good fit for them.
A frequently asked question surrounding your service
A detailed answer to provide information about your business, build trust with potential clients, and help convince the visitor that you are a good fit for them.
A frequently asked question surrounding your service
A detailed answer to provide information about your business, build trust with potential clients, and help convince the visitor that you are a good fit for them.