Services

Our Services

Southern Pharma Consultants, (SPC) offers a full range of consulting services in Quality, and Regulatory Compliance. We also provide consulting expertise including Quality and Compliance audits, Pre-approval inspection preparation, process, utility, computer, and facility validation, provide CMC analytical, formulation, manufacturing, and quality services.

Altabrisa Group advises clients in the pharmaceutical, biotechnology, and medical device industries in development and execution of quality and regulatory strategies for remediation and compliance with ICH and FDA regulations.  

Our consulting services include:  

Data Integrity Assessments – Systems and Data Evaluation

Quality System Audits and Remediation

Quality Audits - Laboratory, Facility, CAPA, Data Integrity

Quality Assurance – Person in Plant (PIP) Responsibilities

Analytical Method Evaluation (Validation, Trend Analysis, Method Performance)

Quality Management

Quality Training

FDA Audit Preparation

Development of Regulatory Responses

Investigation Assessment

Extensive foreign experience

Manufacturing Compliance Oversight

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