The following high quality services are available through BioService Solutions. We can help you affordably meet your compliance goals on time.

FDA Related Activities and Audits

FDA Submissions (NDA, IND, ANDA, NADA, 510k, PMA, DMF, etc.)
Regulatory Affairs
Labeling
Recall Procedure

Audits:
Good Manufacturing Practices
Good Laboratory Practices
GMP for Large Volume Parenterals
GMP for Small Volume Parenterals
GMP for Bulk Pharmaceutical Chemicals
Good Clinical Practices
GMP for Diagnostics & Devices
Application Integrity
Pre-Approval
Quality Assurance and Control
Validation

Quality Assurance Systems and Control Programs

Evaluate Written Procedures and Standard Operating Procedures
Laboratory Systems and Specifications
Self-Evaluation
Sampling Plans
Trend Analysis
Validation/Qualification of Systems and Processes

Computer Systems
Sterile Products Manufacture
Non-Sterile Products Manufacture
Chemical Manufacture of Drug Compounds
Sanitation Systems
Written Validation Procedures and Protocols
Training of Staff for On-going Validation Programs
Technical Assistance

Stability Testing and Expiration Dating Programs
Dosage Form Design and Improvements
Process and Equipment Design and Optimization
Bioavailability/Bioequivalence
Preclinical and Clinical Programs
Development Reports
Computer Controlled Operations Evaluation and Validation

Evaluation and Recommendations

R&D, Manufacturing and Quality Control/Quality Assurance Systems
Evaluation of Human Resources and Capabilities (R&D, Manufacturing, Quality Control/Quality Assurance)
Project Management Optimization
Scale-Up from R&D operation to Manufacturing and Marketing
Documentation Systems

Facilities Design or Validation

HVAC Systems
Water Systems
Sterilization Systems
Dust Control Systems
Assist the Architect and Engineering Company with Designing Appropriate GMP and GLP compliant
Production Facilities, R&D Facilities, Laboratory Facilities, Pilot Facilities

Training

Overview of Regulatory Considerations
Manufacturing Operations and Control GMP Training in
Routine Manufacturing Operations
Documentation Control
Sterile Product Production: Clean Room Techniques, Personnel Practices, Sterilization, Lyophilization
Quality Control Laboratory
On-the-Job Training
Training the Supervisor and the Trainer

Company and Product Acquisitions

We can assist in the Search and Acquisition of Companies and Products