Altabrisa 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

Licensed by the Cyprus Securities and Exchange Commission under licence number 138/11 in accordance with the Markets in Financial Instruments Directive.

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

We are a proud member of the Investor Compensation Fund which acts as a guarantor of last resort for our investors. IFC covers the maximum amount of 20.000 EUR for MiFID clients.

Development of Regulatory Responses

We are a proud member of the Investor Compensation Fund which acts as a guarantor of last resort for our investors. IFC covers the maximum amount of 20.000 EUR for MiFID clients.

Quality System Audits and Remediation

Investor’s money is kept in segregated accounts with top-tier banks that cannot be claimed by creditors or used by us. Account base currencies are available in EUR, GBP, USD, CHF and JPY.

Quality Management

Through the use of an automated transaction monitoring and risk management system, a Consulting WP client’s account will never be allowed to reach negative balance.

Investigation Assessment

Through the use of an automated transaction monitoring and risk management system, a Consulting WP client’s account will never be allowed to reach negative balance.

Quality Audits - Laboratory, Facility, CAPA, Data Integrity

Our Extreme Transparency Policy ensures that the client receives a transparent price feed, transparent liquidity, transparent historical data, transparent market information at all times.

Quality Training

The total value of all of the client’s open positions combined (net open position) may not surpass USD 825.000.000.

Extensive foreign experience

The total value of all of the client’s open positions combined (net open position) may not surpass USD 825.000.000.

Quality Assurance – Person in Plant (PIP) Responsibilities

Licensed by the Cyprus Securities and Exchange Commission under licence number 138/11 in accordance with the Markets in Financial Instruments Directive.

FDA Audit Preparation

We are a proud member of the Investor Compensation Fund which acts as a guarantor of last resort for our investors. IFC covers the maximum amount of 20.000 EUR for MiFID clients.

Manufacturing Compliance Oversight

We are a proud member of the Investor Compensation Fund which acts as a guarantor of last resort for our investors. IFC covers the maximum amount of 20.000 EUR for MiFID clients.

Data Integrity

Assessment

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Remediation

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Quality

Quality Control

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Quality Assurance

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Regulatory

Companies seem to dislike the term ‘turnaround consulting’ because it represents failure. The truth is that turnaround consulting represents success at realizing the company is going in the wrong direction. The only time the company fails is when it is not possible to do a turnaround anymore. We help companies pivot into more profitable directions where they can expand and grow. It is inevitable that companies will end up making a few mistakes; we help them correct these mistakes.

We help companies turnaround their non-profitable ventures into something that benefits them. Our specialty lies in understanding what makes a company special and what makes it tick.

Validation

Companies seem to dislike the term ‘turnaround consulting’ because it represents failure. The truth is that turnaround consulting represents success at realizing the company is going in the wrong direction. The only time the company fails is when it is not possible to do a turnaround anymore. We help companies pivot into more profitable directions where they can expand and grow. It is inevitable that companies will end up making a few mistakes; we help them correct these mistakes.

We help companies turnaround their non-profitable ventures into something that benefits them. Our specialty lies in understanding what makes a company special and what makes it tick.

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Response

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Remediation

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Warning Letter

Remediation

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Response

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