Quality Systems Development and Remediation
As a leading pharmaceutical consulting firm, Edner Scientific LLC offers comprehensive pharmaceutical consulting services designed to help organizations
FDA Mock Audits and Inspection Readiness
Preparing for FDA inspections can be daunting, especially in highly regulated industries like biotech and pharmaceuticals.
Root Cause Investigations & CAPA (Corrective and Preventive Actions)
At Edner Scientific LLC, we are dedicated to helping companies in the biopharmaceuticals consulting and pharmaceutical consulting sectors address complex
Validation Services
Validation is a key component of any pharmaceutical consulting process, and at Edner Scientific LLC, we specialize in providing expert GMP Validation services for companies
FDA 483 and Warning Letter Remediation
Dealing with FDA actions such as 483 Observations or Warning Letters can be overwhelming for companies in the biopharmaceutical and pharmaceutical consulting industries.
GMP Compliance Auditing
Maintaining compliance with Good Manufacturing Practices (GMP) is essential for success in the biotech, biopharma, and pharmaceutical industries.
Training & GMP Compliance Support
At Edner Scientific LLC, we believe that employee training is critical for maintaining long-term compliance in the pharmaceutical and biopharma industries
Remediation Project Management
Managing remediation projects in the biotech and pharmaceutical industries requires expertise, precision, and regulatory knowledge. At Edner Scientific LLC,
GMP Compliance Auditing
Maintaining compliance with Good Manufacturing Practices (GMP) is essential for success in the biotech, biopharma, and pharmaceutical industries.