At Pharmatech, we understand the science of manufacturing, the rules of compliance and the demands of business. This unique combination of services defines our commitment to the regulated life sciences industry.

From compliance strategies and quality systems development to auditing and corrective action implementation, our people are known for original thinking, innovative ideas and the ability to work with all levels of an organization. From parenteral, oral, liquid and solid dosage forms to stem cells, combination products, medical devices and diagnostics, we work with our clients to generate new ideas and solutions, helping companies and research institutions accelerate the development and execution of innovative and effective quality management strategies.

Pharmatech's services range from policy and procedure development to assessment/audit and surveillance/PAI readiness. We apply our real-world experience to the development of quality systems, which are appropriate for the maturity of our client's organization. This is done to assist them in achieving cGMP compliance and building quality systems.

Regulatory Compliance
As regulations evolve and penalties for non-compliance become focused, avoiding regulatory sanctions, recalls and delays is now key to survival and success-not only for the product, but in some instances for the entire company. Pharmatech's approach to regulatory compliance is based on the premise that the most cost-effective solution is a plan of action. Implementing that plan, however, requires deep understanding of the issues and challenges involved.

At Pharmatech, we assist our clients in developing a plan based upon their compliance history, their challenges and a thorough analysis of the data. Only then do we offer recommendations and solutions to gain control over compliance gaps and reduce the overall risk of non-compliance. We then go one step further. We provide the resources and expertise, including inspectors from our team with significant agency experience necessary to speed the implementation of those recommendations.

Pharmatech's quality development services cover:

Strategic Planning: Our strategic planning process transforms quality and business objectives into tactical initiatives that enable regulatory compliance to be achieved across the organization.

Corrective Action Programs: By employing active monitoring of FDA-483s, Warning Letters and other legal sanctions, Pharmatech can translate observations into terms that help maintain timely and orderly execution of corrective and preventive actions.

Project Management: Through skillful planning, scheduling and implementation, Pharmatech expedites corrective and preventive actions in a way that compresses time, streamlines activities and maintains rigorous control over project implementation.

Product Development and Manufacturing: Our use of risk-assessment tools and techniques can enhance your regulatory compliance profile, while offering further options for optimizing your product development and commercial manufacturing operations.

Regulatory Liaison: Pharmatech has extensive experience working with regulatory agencies. Our insight can help improve your credibility by identifying what is really important, and then communicating reasonable objectives and timeframes for addressing compliance concerns in a way that represents your best interests.

Quality Systems Development
As our clients navigate the complexities of the product development lifecycle, it is imperative that their quality systems be capable of supporting the escalating quality requirements as product moves to market. Many quality initiatives fail because they involve a solution that is not practical for the organization. At Pharmatech, our experts understand the quality issues facing regulated life science companies, and they know how to solve them with simple, effective solutions. From designing quality systems through implementation, our professionals seek to understand your quality agenda.

By using a proven quality systems assessment methodology, Pharmatech can quickly identify strengths, weaknesses and opportunities to improve your organization's quality program. Our professionals work with you from the earliest stages of conceptual design to provide hands-on experience in writing quality standards, policies and procedures that are tailored to the maturity of your organization and the compliance needs for your business. Pharmatech's professionals will propel you through the implementation process, ensuring that your quality system functions properly and meets your business requirements at every step.

Specific systems developed and deployed for our clients:

• Quality Manual
• CAPA
• Change Management
• Validation Policy and Procedures
• Calibration and Preventative Maintenance
• Training
• Environmental Monitoring
• Operating Procedures

Auditing
At Pharmatech, our approach to compliance auditing is proactive. Our audits are performed by professionals who understand worldwide regulatory requirements, track inspection standards and provide the highest quality review for regulatory compliance. Pharmatech's auditors classify the severity of all deficiencies identified, and unlike many consultancies, we provide our clients with a clear path to resolving the deficiency.

We work with venture capital start-ups and leading multi-national corporations to perform GMP, GLP, QSR, ISO, DEA, Design Control, Vendor-Supplier and Computerized System audits. Pharmatech's capabilities cover the complete life cycle of a product, from research and development through commercial manufacturing.

Pharmatech offers the following Audit Services:

Compliance Audits: Utilizing a proven approach to audit, Pharmatech will evaluate your methods, facilities and controls for compliance against regulatory expectations. These audits help identify problem areas prior to inspection by regulatory authorities and include prioritized remedies and corrective actions to be taken.

Mock Regulatory Inspections: Our mock regulatory inspections will challenge your organization to the fullest extent, so that your employees know how best to deliver information to regulatory investigators. Consequently, you pass your inspection the very first time, every time.

Due Diligence Audits: Our due diligence assessments evaluate the compliance status of potential manufacturing facilities, laboratories and packaging operations. Special consideration is given to the systems in place to support the relationship between our clients' quality systems, operational systems and supply chain.

Specific audit services offered by Pharmatech include:

• Validation Systems
• cGMP Gap Analysis
• PAI Readiness - Validation, cGMP, CMC, Device
• Supplier Qualification - API, Raw Material, Analytical, Equipment/Automation, General Contractor
• Laboratory GLP
• Training

ISO 9000
The ISO 9000 standards provide a framework upon which to build a management system that ensures customer satisfaction by reducing non-conformance and variation in work processes, products and services. Consultants need to be knowledgeable about quality issues, the standards, and auditing and documentation practices.

Pharmatech retains certified Lead Assessors that have overseen multiple ISO 9000 system deployments. Our consultants assist clients in the development of the specific systems needed to achieve and maintain ISO certification. We understand how business strategy development, project management and resource budgeting are related to the successful implementation and maintenance of ISO 9000 certification.

Global Regulatory Experience
Pharmatech has experience developing quality systems that meet the varied requirements of regulatory agencies outside the United States, including the Medicinals and Chemistry Agency (MCA), European Medical Enforcement Agency (EMEA), Danish Medicines Authority (DMA), and Japanese Regulatory Agency (Ministry of Health). The knowledge of these regulations allows Pharmatech to guide clients in their facility design, and suggest process and product design and operations alternatives.