AccuReg Inc.

4400 SW 95 Avenue
Davie, Florida 33328, USA
Ph: 954-641-6400 / Fax: 954-641-6410
http://www.regulatory.com / accureg@regulatory.com


Welcome to our Services Brochure

AccuReg is a regulatory, compliance and technical consulting firm serving the pharmaceutical, medical device and diagnostic, and over-the-counter drug industries. Since 1987, we have helped hundreds of domestic and international clients to achieve compliance with FDA's Good Manufacturing Practices and other regulatory requirements, gain U.S. market approval and ensure the quality of their products.

AccuReg provides a full range of consulting and technical services. Our participation ranges from guidance and advice, to on-site collaboration and training, to turnkey delivery. Our primary service areas are:

In this brochure, you will find the following sections:





Brief Description of Services

Quality Systems, Compliance and Engineering: Quality System development and implementation, FDA 483 and Warning Letter responses and action plans, complaint handling and CAPA systems, documentation systems, validation master plans, Business Process Re-Engineering (BPR), design control implementation, process automation and control, process analysis/methods improvement, production equipment procurement, relocation and qualification, training in QS Regulations, GMPs, GCPs, and GLPs

Audits: GMP and QS Regulation compliance audits, GLP audits, simulated Pre-Approval inspections, Electronic Records/Electronic Signatures (ERES, 21 CFR Part 11) audits, GCP, bioresearch and clinical study audits, design control audits

Software Services: Validation and verification plans, risk analysis, 510(k) submissions, Quality Systems development and implementation, quality audits, design control process development, implementation and training, ERES audits and action plans, V&V training, implementation of traceability solutions using the DOORSÒ family of automated requirements management tools

Clinical Services: Regulatory due diligence and feasibility evaluations, clinical protocol development and review, Case Report Form (CRF) development and review, Advisory Committee Meeting presentations, Investigator Meeting coordination and participation, IRB selection and review, clinical site selection and review, bioresearch/clinical study audits, SMO/CRO audits, pre-IND/IDE meetings, end-of-Phase II meetings, etc.

FDA Submissions: Regulatory and product development strategy, regulatory "roadmaps," due diligence and feasibility evaluations from a regulatory perspective, Pre-market Notification [510(k)] Applications, Investigational Device Exemptions (IDEs), Pre-market Approval Applications (PMAs), Investigational New Drug Applications (INDs), traditional and Abbreviated New Drug Applications (NDAs and ANDAs), Biologic License Applications (BLAs), Drug, Device and Biologic Master Files, establishment registrations and product listings

Company Background

AccuReg, founded in 1987 by Loui J. Silvestri, Ph.D. and H. Ruth Pyle, RAC, serves the healthcare industries with expert regulatory, compliance and technical support. Our Associates are Regulatory Affairs professionals, chemists, engineers, biologists, quality specialists and technical writers with industrial and regulatory experience. Their backgrounds are in:

Collectively, our Associates have worked across the full range of medical products, from novel pharmaceuticals, parenterals and sustained release dosage forms, to sunscreens and other OTC formulations; from Class I Exempt to Class III devices; from simple to complex IVDs; and from low- to high-risk software.

In addition to our in-house staff, AccuReg maintains a network of highly qualified Affiliate Associates with whom we have worked for years. These individuals supplement our core team with additional experience and specialized expertise, allowing us to effectively serve clients with extensive or long-term projects at various locations in and out of the U.S. All of our Affiliates meet the high standards for credentials and experience required of our in-house Associates, and their qualifications are tried and proven before any client assignment is made.

AccuReg takes pride in our team. We believe they are the best professionals in the industry.

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Mission/Goals

While the regulations are printed in "black and white," each client's product is unique. Therefore, an understanding of the product and realistic, appropriate interpretation of the regulations in relation to that client's product are essential. We strive to ensure that clients are neither vulnerable to quality deficiencies and regulatory action, nor burdened with unnecessarily restrictive or elaborate processes that are inappropriate to the product or company. Our Associates and Affiliates work collaboratively and creatively with each client to achieve this balance.

Our Principals

As President of AccuReg, Loui J. Silvestri, Ph.D. is responsible for the firm's overall scientific, technical and compliance services, and he has worked successfully with numerous client firms to win FDA approval and maintain product compliance. His combination of scientific knowledge and regulatory affairs expertise is the guiding principle behind AccuReg's comprehensive program of services. In addition to directing the activities of the company's Pharmaceutical and Medical Device Divisions, Dr. Silvestri also oversees the firm's software validation group. He is an industry-recognized expert on electronic records and signatures (21 CFR Part 11), software and computer system validations, and other regulatory issues related to regulated electronic systems and data.

Dr. Silvestri earned his doctorate in immunology and cell science from the University of Florida and performed post-doctoral research in immunochemistry and clinical immunology at the University of Alabama Medical School. He is a founder and past-President of the Allergen Products Manufacturers' Association. His pharmaceutical management background includes six years at Key Pharmaceuticals and Schering-Plough, where he was a Director in the department of Allergy and Immunology, overseeing R&D, Clinical and Technical Affairs.

H. Ruth Pyle, RAC Executive Vice President, is a Regulatory Affairs Certified professional with more than 20 years of practical scientific, regulatory and management experience. At AccuReg, she is responsible for the firm's overall regulatory services and directs the Clinical Services Division. She has directed the preparation of numerous product approval, clearance and marketing submissions, and works extensively with client firms to realize the successful commercialization of new products. An expert in FDA compliance and Good Clinical Practices, Ms. Pyle frequently works with clients to design clinical studies, develop and review clinical protocols, and perform clinical study, CRO/SMO and bioresearch audits. She also coordinates and leads pharmaceutical manufacturing facility and documentation audits, and simulated Pre-Approval Inspections.

Prior to founding AccuReg with Loui Silvestri, Ms. Pyle was responsible for regulatory and clinical affairs, pharmaceutical manufacturing, quality control, and product development at major pharmaceutical firms such as Sandoz, Key Pharmaceuticals and Schering-Plough. She holds a degree in Chemistry from Creighton University, with additional formal training in Business Management and Administration.

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DETAILED DESCRIPTION OF SERVICES

Quality Systems, Compliance and Engineering:

For pharmaceutical, medical device and OTC companies, AccuReg offers guidance and "hands on" support in the following critical compliance areas:

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Audits

Audits are an essential quality tool for verifying compliance, good practices and progress. In addition, they are often the first step to developing an action plan in areas where "opportunities for improvement" are already known to exist.

AccuReg's standard practice is to conduct each audit with an eye to solutions. Our audits are as broad and deep as the situation warrants and your priorities dictate. After the inspection is complete, we generate a detailed written report or high-level written summary documenting our observations. Again, the scope of the report is dependent on your goals for the audit and the format that best serves those goals. All audit reports include recommendations for corrective actions. At your request, we can also help you prioritize the action items, develop a formal plan and work with your staff or vendor to implement the recommendations.

We offer:

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Software Services

Our software services are designed to support the compliance of medical-device software and systems, Quality System software and systems, clinical data management and analysis software and systems, product testing and manufacturing systems, and electronic records/electronic signatures systems. We are experienced in the successful development and filing of 510(k) submissions for software medical products and have worked extensively with a variety of proprietary and commercial software products to develop sound validation plans and design control processes.

Additionally, in response to the need for automated traceability to support the lifecycle of many complex and extensive software products, AccuReg is a licensed distributor of the DOORSÒ family of automated requirements management tools, manufactured by Telelogic. For suitable projects, we offer custom-design-control solutions that can include any combination of the following: risk analysis, requirements, design document and validation plan development, and established traceability and control through a DOORSÒ product, delivered to the client with their software license and Standard Operating Procedures for maintaining design control.

Other software services include:

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Clinical Services

AccuReg's clinical services focus on identifying and preventing or correcting problems before they impact on the quality, integrity or duration of the study. PharmDs, Ph.D.s and medical and regulatory professionals staff our clinical division. They possess extensive practical experience in industry and academia. Note: AccuReg is not a CRO or SMO, and does perform routine clinical monitoring. Our Clinical division is an auditing, design review and Quality Assurance resource.

Our bioresearch auditing services include:

Other clinical services include:

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FDA Submissions

AccuReg is experienced in the preparation, critical review, assembly and filing of the following regulatory submissions for pharmaceutical and medical device products:

Our Associates can work with your team to coordinate development of entire submissions, prepare turnkey inclusions (e.g., CMC sections, data analyses, validation reports, literature summaries, etc.), or any combination of participatory services.

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Partial List of Clients

Following is a sampling of our Fortune 500 and other client companies.

ADAC HealthCare Information Systems

Alcon Laboratories

Bausch & Lomb Pharmaceuticals

Creative Cosmetics, Inc. (CCI)

Dermtek Pharmaceuticals, Ltd.

Dow Chemical Company

Florida Chemical Company

FluoroMed, LP

Home Diagnostics, Inc.

Lemmon Company / Teva Pharmaceuticals USA

MedNext, Inc.

National Medical Care

Nelco Laboratories, Inc.

Neoprobe Corporation

Northwestern University Medical School

Promega

Soule Corp.

Sample Projects

Following is a partial list of our successfully completed projects and the types of companies who engaged us.

Quality System Implementation

Compliance Audits

Software Validation, ERES, and Software Quality Services

Clinical Services (Audits, Protocol Review and Medical Summaries)

FDA Submissions

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Client Comments

"Just a quick note to thank you for the timely and thorough assistance you and your staff provided us recently. We especially appreciated your advice on regulatory strategies and suggestions for responses. I am sure this is true for most of your clients, but when we need help, we need it now! Your team never fails to recognize our priorities. Despite the other commitments your firm surely must have, AccuReg has always responded to our needs as if we are your only client."

--Allergen product manufacturer

"Thank you for the excellent job you and your staff did in conducting validity assessments ... I want to complement you and your staff for keeping all of your commitments to complete each individual report on time. The completion of the reports on time was very important to FDA, and therefore, to our success in keeping our products on the market...."

--Prescription pharmaceutical manufacturer

"Thank you for your outstanding assistance in the preparation and submission of the 510(k) ... Your staff is to be recommended for their attention to detail, and therefore their quality of work. I am very pleased with the outcome of our relationship - successful clearance of the submitted 510(k), and the guidance provided during this endeavor that allowed for a successful GMP audit."

--Blood bank software manufacturer

"I would like to take this opportunity to sincerely thank you for the quality and timeliness of the gap analysis ... You succeeded where others have failed in working with the technicians at the lab, teaching them along the way, while remaining sensitive to their needs and concerns. Your clear, in-depth report is a reflection of your excellent knowledge and expertise in the field of software systems validation."

--Ophthalmic products manufacturer

"I would like to take this opportunity to thank you and your staff for years of excellent regulatory, compliance and technical guidance and support. As a result of your efforts, [our company] has developed a firm commitment to quality, as demonstrated by our most recent FDA inspection. As you are aware, that occasion resulted in only one minor citation on our Form 483."

--Contract manufacturer, prescription and over-the-counter pharmaceuticals

"Your recommendations regarding clinical development plans, FDA issues, IND reviews, strategic planning for FDA meetings, 510(k) reviews and GMP issues for the manufacturer of both the radiolabeled monoclonal antibody and gamma-detecting probe have been invaluable."

--Developer and sponsor, proprietary biotech products

"As you know, we have used the services of AccuReg to perform our semi-yearly internal GMP audits since the inception of [our company]. Due to the excellent recommendations of AccuReg and our willingness to make changes and improve our GMP system, we have always felt that we have done a good job meeting the requirements of the FDA's GMPs. In January of this year, we were inspected by the FDA ... The inspection lasted four days and covered all aspects of the GMP. We are proud to say that we received no Form 483 comments from the inspection ... We feel that AccuReg is directly responsible for this excellent result, and we look forward to working with you in the future."

--Manufacturer, surgical bone drills

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Do you have questions or require expedited service? Would you like to obtain a list of client references, full curricula vitae of our staff, or a hard copy of our brochure? Contact us at your convenience by e-mail to accureg@regulatory.com, calling us at 954-641-6400, faxing us at 954-641-6410, or writing us at 4400 SW 95 Avenue, Plantation, FL 33328, USA. All inquiries and project evaluations are completely confidential and without obligation.





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