North American Suppliers Directory Index

Quintiles Consulting

1801 Rockville Pike, Ste. 300
Rockville, MD 20852 USA
Tel: 301/272-2149
Fax: 301/272-0004

Web: http://www.quintiles.com/consulting
E-mail: qcon.web@quintiles.com

Quintiles Consulting is truly in a class of its own. We provide global regulatory, compliance and validation consulting services to the pharmaceutical, biologics, and medical device industries. And we offer product development services to the medical device industry.

We are results focused and have established an impressive record of tangible benefits for our customers –cadre of experts include former FDA investigators, district office managers, and headquarters product reviewers and managers. These are complemented by seasoned industry experts with years of "know-how" in designing and implementing compliant systems.

Whether your needs are small – an hour of expert advice, or large – fulfilling the requirements of an FDA consent decree, Quintiles Consulting has the depth in expertise and resources to fulfill them.

Quality Systems/Validation/GXP Compliance...

Quintiles Consulting has developed a track record of successes in helping pharmaceutical, biologic, biotech, tissue, blood and medical device companies establish robust, sustainable quality systems. Our unique Core Team™ strategy embraces an interdisciplinary, risk-based, systems-oriented approach. It assures that the resulting quality system is owned by the company...and not a "shelf document" residue of a horde of consultants. Our consultants contribute examples of best-of-class industry standards, provide technical and regulatory support, and provide an independent third-party perspective. The benefits of an effective quality system go beyond just GMP, QSR or ISO compliance. A quality system provides an abundance of business returns in the form of reduced waste/loss, reduced rework, improved cycle time, enhanced efficiency, process optimization, and improved customer satisfaction, among others. An ROI on investments in a quality system are demonstrable.

A unique feature of our Core Team™ strategy is our use of tools and techniques to help optimize manufacturing processes. Our strategy marries improved efficiency (with a strong return on investment) and the establishment of a robust quality system. This marriage assures that manufacturing efficiencies do not put your company at risk of producing defective product or precipitating criticism by regulatory authorities.

An integral element of an effective quality system is an effective and efficient validation program that encompasses software and hardware, laboratory and manufacturing equipment, manufacturing processes, and test methods. Quintiles Consulting offers a broad spectrum of validation services using quality system and cost-effective management principles. These include strategic validation assessment and consultation; validation master planning; equipment qualification (IQ); operational qualification (OQ), process qualification (PQ), process validation, protocol development and execution; facilities/new construction commissioning; computer/software validation; and Part 11 compliance. Our use of risk-based techniques assures a least burdensome validation approach and provides means for prioritizing validation activities. We have pioneered innovative and cost-effective validation strategies such as Common Process Validation, Product Assessment Technique™ and ComplianceReady™.

Our Common Process strategy maximizes efficiency by identifying processes common to multiple products and validating them as standalone processes. This avoids redundant and repetitive validations for individual products that may use the common process. FDA has recognized the benefits and value of this strategy.

Our Product Assessment Technique™ (PAT) program has been designed to provide scientific rationale using risk-based techniques to assess and remediate products that have undergone various changes over time. The PAT updates design documentation for each change, provides opportunity to assess all changes in the aggregate and characterizes the product to enable appropriate control of future changes. The PAT process is particularly valuable in providing documentation for decisions to perform or not to perform additional verification and/or validation activities. It also provides documentation to support decisions as to whether a new 510(k) should be submitted as a result of changes. This strategy has also been considered and accepted by FDA.

ComplianceReady™ is a risk-based approach to software validation and 21 CFR Part 11 compliance. It provides a rationale for prioritizing validation and Part 11 remediation activities and provides justification for an appropriate level validation/remediation. ComplianceReady™ is suited for operational systems, manufacturing systems, quality support systems, clinical systems and laboratory systems.

We recognize that creating a quality system on paper is not enough. Changing documents is easy compared to the task of changing behaviors. Organizational culture and behaviors must be supportive and in alignment with the quality system.

In conjunction with our Core Team™ strategy, our Quality Alignment Program provides means to assess organizational culture and change behaviors to assure the successful implementation of the quality system.

Our strategies and expert consultants help create quality systems that are:

• Robust – A robust quality system is comprehensive; provides financial benefits, facilitates operational excellence and efficiency and improves customer loyalty. In addition a robust quality system insures compliance with the requirements of GMP, QSR, GCP, GLP, and other FDA/state/local/international statutes/regulations.
• Usable – The quality system must be practical. It must be compatible with and supportive of the company's business needs. It must include systems that make sense, are not overly burdensome and can be effectively executed.
• Sustainable – The nature of an effective quality system is that it continues to evaluate, provide feedback and facilitate improvement over time. This can only happen if the quality system is supported and maintained by the organization. Therefore, to be sustainable, the quality system must be owned by the organization. It cannot be a template or shelf-document created by someone else.
• Efficient – Quality systems can be effective yet efficient. Investments in quality should be evaluated in the same manner as other company expenditures, i.e. in terms of expected return. Risk-based tools particularly when coupled with process optimization efforts provide assurance that quality processes will not be unnecessarily burdensome and additive to the overall efficiency of production operations.

The diagnostic independent third-party audit conducted by Quintiles Consulting as the foundation for the development or enhancement of a company's quality system has also proven valuable to company's who want to assess the capabilities of a vendor or contract manufacturer. Companies have used our audit capabilities to complement their due diligence activities when considering an acquisition.

FDA Inspection and Compliance Strategic Advice...

Unfortunately, companies sometimes find themselves facing threatened or real FDA enforcement action. Quintiles Consulting is uniquely qualified to provide advice and assistance in parrying-off or resolving FDA enforcement efforts. Our staff of former FDA investigators, district directors, regional directors and Center compliance directors have matchless skills and insights to FDA’s policies, procedures and, most importantly, its thought processes. In fact, many of these enforcement policies and practices were established by our staff when employed at FDA. We can help guide your interactions with FDA from a response to an FDA 483, a Warning Letter, an injunction (consent decree), recall or other such enforcement action.

Preparation is the best way to prevent an FDA enforcement action. Knowing your regulatory vulnerabilities provides opportunity to make corrections well before an FDA inspection. Our Gap Analysis, Mock FDA Inspection or a combination of the two provide an objective, third-party perspective enabling establishment and prioritization of necessary corrective actions. We can assist in the development and execution of Corrective Action Plans to assure compliance and avoid FDA enforcement. Our well established relationships and credibility with FDA staff have proven valuable in obtaining acceptance to proposed corrective actions and acceptance of completion thereafter.

On occasion, our customers and FDA have found beneficial our review and third-party certification of certain activities as assurance of product integrity. This has included final review and acceptance of production records for product release; failure investigations, CAPA records, complaint investigations, recall decisions, and health hazard determinations. These certifications and verifications have, in some cases, served as an alternative to FDA enforcement action and provided time to the company to make comprehensive corrective action.

Since most FDA enforcement actions begin with an inspection, it is imperative that companies know how to effectively manage FDA inspections. Having an effective quality system doesn’t necessarily assure a successful FDA inspection. Surviving an FDA inspection unscathed requires skill, organization and confidence. Knowing how to effectively interface with an FDA investigator; who in the company can or should speak to the investigator; understanding the investigator's authorities; being aware of which documents must be produced and in what format; knowing how to be responsive without confessing; how to respond to the FDA-483 during the inspection; knowing whether to request annotation of the FDA-483; what to do if you disagree with the investigator or if the investigator has made a mistake; and how to manage the entire inspection process are just a few issues that a company needs to address and prepare for before the inspection. Failure to manage the inspection can result in erroneous conclusions by the investigator and precipitate unnecessary follow-up scrutiny by FDA. Our former FDA investigators and FDA field office managers have developed training programs that provide the "rules" of the game, but also provide unique insights into FDA enforcement processes and the FDA thought process.

Surprisingly, nearly 20% of companies fail FDA Pre-Approval Inspections (PAIs). Quintiles Consulting has developed a unique program MarketReady™ designed to assure success during a PAI. This program benchmarks a company's preparedness against 10 GMP milestones. These milestones were identified by our experts who, as former FDAers, actually participated in the development of FDA's PAI programs for both pharmaceuticals and medical devices. MarketReady™ provides assurance that no time getting to market will be wasted because of a failed PAI.

Bioresearch Program...

Our Bioresearch Program provides assurance that FDA product approvals will not be delayed or compromised because of unreliable study data or failure to comply with regulatory requirements during conduct of clinical trials. We have developed strategies that have been successful in helping companies that have been subjected to FDA's Application Integrity Policy (AIP), had a study (IND, IDE) put on hold, or received an NDA or PMA "not approval" letter because of unreliable data. Even in these dire circumstances, we have helped companies re-establish the credibility of clinical data and save valuable submissions.

Our former FDA investigators and industry clinicians conduct independent assessments of clinical investigators, sponsor/monitors, laboratories and IRBs to identify problems so they can be corrected before they adversely impact a clinical study or an FDA submission. These experts understand the requirements of Good Clinical Practices (GCP), Good Laboratory Practices (GLP), 21 CFR Part 50 - Informed Consent, and Part 56 – Institutional Review Boards as well as International Conference on Harmonization (ICH) guidelines.

Medical Device Development...

Have an idea or technology with medical applications? Want to know how to develop it and get it through the world's regulatory quagmires to global markets? Quintiles Consulting has unique capabilities to help you commercialize your ideas efficiently and cost-effectively. Our staff consists of former FDA Office of Device Evaluation reviewers and former European Union regulators. These experts are strategically located throughout the United States and Europe.

Our experts can help determine the best place in the world to seek marketing clearance/approval; which form of clearance/approval is most beneficial (510(k), PDP, PMA, CE); identify cost-effective strategies for obtaining supporting data; develop clinical protocols; manage and execute clinical trials; analyze and interpret clinical data; and prepare regulatory submissions.

Our staff has expert knowledge of the evolving regulatory scheme for combination products. Having developed FDA guidance documents for combination products, members of our staff have unique insight and understanding of FDA's objectives and manner of regulating these products.

In addition, our European capabilities also include translation services; reimbursement and pricing strategies; vigilance reporting; intimate understanding of ISO 9000; 13485; En 46000, Medical Device Directive (MDD), IVD Directive; and authorized representation through our Ar-Med Ltd subsidiary.

Training...

Quintiles Consulting provides training in quality systems, compliance, product development and validation for the pharmaceutical, medical device, and biologics industries. Our programs are enriched by the expertise of a staff that includes former FDA, EU, and industry professionals who are recognized authorities in the areas of QSR, GMP, ISO, FDA compliance, GCP, GLP, product development, and validation. Our programs include current industry practice, highlight "best practices," and address all pertinent regulatory and international requirements. Quintiles Consulting's highly interactive programs use contemporary adult learning techniques to assure that your employees absorb the material and can perform their responsibilities. We also offer customized training to meet the specific regulatory and business needs of each client.

QSourcing...
Need an extra pair of hands...not just a body, but a pair of educated hands? Don't need a consultant or want to pay a consultant's fees? QSourcing, a service of Quintiles Consulting, was created to meet your special needs for temporary staffing. Because QSourcing specializes only in placements for the pharmaceutical, biologic and medical device industries, it understands the special needs and skills required for interim placements in these industries. QSourcing can provide technically skilled and capable individuals to operate under your supervision. Whether you need an engineer for a special validation project; someone to fill a vacancy while you recruit, a mid to upper level manager to oversee a project, activity or department, QSourcing can help.

Categories this company is listed under in the North American Suppliers Directory:

• R&D, Design, and Business Services: Consulting/Training services (384 companies)
• R&D, Design, and Business Services: Facility design (62 companies)
• R&D, Design, and Business Services: Process validation/QC (237 companies)
• R&D, Design, and Business Services: Product design (637 companies)
• R&D, Design, and Business Services: Software development/Validation (222 companies)