Group Manufacturing Practices GMP | Good Clinical Practice GCP

eCTD SOLUTIONS
AUDITING DOCUMENTATION TRAINING

AUDITING:
Pharmaceutical On-Site Visits,
Remote Clinical Trial Monitoring,
Staff Training

GCP - GMP - GLP CERTIFIED:
Quality,
Document Management,
Staff Training

eCTD SUBMISSIONS:
NDAs, ANDAs, BLAs, INDs, DMFs,
Annual Reports, Amendments, Adverse Event Reports,
Supplements

FDA Connection Group, Inc. is a 3rd party FDA consulting group specializing in analytical, clinical, regulatory, and compliance affairs specific to FDA. Our Team meets and exceeds Good Clinical Practices, Good Manufacturing Practices, Good Laboratory Practices, Quality System Regulations, International Conference on Harmonization, and International Organization for Standardization (GCP/GMP/GLP/QSR/ICH/ISO) requirements for the Pharmaceutical, Medical Device, and Biologic industries.

This is what we do

Provide superior customer care to our clients
Respect and value our relationships with all parties
Exercise time efficient Remote and/or On-site visits
Create and submit thorough essential documents
Together, bring your company into Compliance and Approvals

eCTD SOLUTIONS AUDITING DOCUMENTATION TRAINING

AUDITING:Pharmaceutical On-Site Visits,Remote Clinical Trial Monitoring,Staff Training

GCP - GMP - GLP CERTIFIED:Quality, Document Management,Staff Training

eCTD SUBMISSIONS:NDAs, ANDAs, BLAs, INDs, DMFs,Annual Reports, Amendments, Adverse Event Reports, Supplements

This is what we do

eCTD SOLUTIONS
AUDITING DOCUMENTATION TRAINING

AUDITING:
Pharmaceutical On-Site Visits,
Remote Clinical Trial Monitoring,
Staff Training

GCP - GMP - GLP CERTIFIED:
Quality,
Document Management,
Staff Training

eCTD SUBMISSIONS:
NDAs, ANDAs, BLAs, INDs, DMFs,
Annual Reports, Amendments, Adverse Event Reports,
Supplements