Compliance Engineering Reference Guide Index

Bio-Reg Associates Inc.

11800 Baltimore Ave., Ste. 105
Beltsville, MD 20705 USA
Tel: 301-623-2500
Fax: 301-623-2600

Web: http://www.bioreg.com
E-mail: marketing@bioreg.com

BIO-REG Associates, Inc. is a leading regulatory consulting firm dedicated to assisting medical device, biologic, pharmaceutical, and biotech manufacturers bring their products to market. Strategically located near FDA in the Washington, D.C. metropolitan area, we help our clients, both international and domestic, meet the US and international regulatory, quality control, and clinical study requirements. We also offer Electromechanical Lab, In Vitro Diagnostic Lab and Incubator Services. At BIO-REG, we recognize the importance of providing a quality service. Thus, we strive to not only meet but also exceed our client’s expectations. Whether your company is facing regulatory issues for the first time, or is confronted by a new regulatory challenge, BIO-REG can work with you to make your regulatory path smoother and more efficient.

Company Profile

Founded in 1987, BIO-REG is a privately owned, incorporated company. BIO-REG’s success depends on its highly qualified and dedicated employees. BIO-REG is staffed by business, regulatory, quality, and clinical professionals. Members of the firm include specialists in FDA Good Manufacturing Practices (GMP) and Quality Assurance Regulations (QSR), diagnostics, product design, regulatory compliance programs and clinical studies monitoring and management. BIO-REG’s management team is comprised of proven industry leaders. Thus, BIO-REG’s comprehensive base of expertise permits clients to draw upon knowledge and skills that can be uniquely tailored to their business requirements and corporate goals.

BIO-REG is experienced in assisting domestic as well as international companies achieve their US and international regulatory goals. In fact, BIO-REG’s client base consists of over fifty percent international companies.

Services

BIO-REG has a proven track record managing all aspects of regulatory affairs. Our comprehensive range of services include:

• Regulatory Consulting Services
  Regulatory Affairs is an integral part of any company looking to successfully sell their medical products in today’s market. FDA requirements and policies frequently change, drastically affecting the product approval process. BIO-REG’s Regulatory Services helps you meet the regulatory requirements for your product.

  These services include: Regulatory Strategy Development, Preparation and Submission of 510(k), IDE, PMA, IND, NDA, ANDA, BLA, Applications and Initial and Annual Product Reports, FDA Liaison, Response to FDA 483 Letters, and Device Master File (MAF) Development and Revisions

• Manufacturing Quality and QSR/GMP Compliance Services
  Successful market introduction and continued product distribution are the lifelines of any medical manufacturer. Of the many factors that contribute to a company’s success, compliance with FDA’s manufacturing Quality Systems/GMP regulation is of utmost importance. In addition to implementing new QSR/GMP systems, BIO-REG has successfully redesigned manufacturing QSR/GMP and quality programs for companies in non-compliance with FDA regulations.

  These services include: Audits (i.e. QSIT Approach, ISO), Quality Training, Protocol Development, Product and Process Validation, Validation Reports, Assessments, Compliance Program Development, Quality Assurance/Quality Control (QA/QC) Program Development, Audit Reports, Action Plan Development and Implementation. Additionally we offer IQ, OQ, and PQ qualifications as well as software validations and verifications.

• Clinical Study Design and Management Services
  BIO-REG’s Clinical Services offers a broad range of products to ensure that every facet of a clinical study meets FDA requirements thus generating the necessary data for product approval.

  These services include: Protocol Development, Investigator Selection, Case Report Form Development, Patient Consent Form, and Computer Database Development, Investigator Agreement Development, Investigator Manual Development, Facilitation of IRB Approval Process, Planning and Conducting Principal Investigators Meeting, Monitoring, Data Management and Analysis, and Study Reports

• Electromechanical Laboratory Services
  We can either perform your medical device testing or assist you in selecting the appropriate tests for you to perform. In addition, we have laboratory space available should you want to conduct your own testing in our facility.

  Our Testing Services include: Regulatory Test Requirements Identification, Protocol Development, Product Performance Testing, Test Result Interpretation, Material Characterization Testing, Mechanical Testing, Electrical Testing, Thermal Testing, and Safety Testing

• Diagnostics (IVD) and Laboratory Services
  BIO-REG’s Diagnostics Consulting and Lab Services provide you with an unlimited breadth and depth of IVD experience in areas of clinical trials, FDA submissions and manufacturing scale-up.

  These services include: Feasibility Testing, Assay Development, Product Validation, Clinical and Non-Clinical Evaluation, Manufacturing Transfer and Optimization

• Incubator
  The BIO-REG Incubator helps you develop your product as well as obtain regulatory approval to gain entry in the vast medical market. The Incubator offers a unique package including office/laboratory space and on-site consulting services. These include regulatory assistance, quality control, clinical studies management and business support matters. The Incubator also offers access to both our freestanding EM Lab and IVD Lab.

Categories this company is listed under in the Compliance Engineering Reference Guide:

• Test Equipment and Software (EMC, ESD, Telecom, Environmental, and Safety): Software: Medical Devices (20 companies)
• Test Equipment and Software (EMC, ESD, Telecom, Environmental, and Safety): Software: Quality (23 companies)
• Test Equipment and Software (EMC, ESD, Telecom, Environmental, and Safety): Software: Standards and Regulations (26 companies)
• Testing and Services: Services: Consultants, EMC (182 companies)
• Testing and Services: Services: Consultants, Medical Device (116 companies)
• Testing and Services: Services: Consultants, Product Safety (130 companies)
• Testing and Services: Services: Consultants, Quality (91 companies)
• Testing and Services: Services: Training, Medical Devices (59 companies)
• Testing and Services: Services: Training, Product Design for Compliance (84 companies)
• Testing and Services: Services: Training, Product Safety (84 companies)
• Testing and Services: Services: Training, Quality (69 companies)
• Testing and Services: Testing: Medical Devices (151 companies)
• Testing and Services: Testing: Product Safety (150 companies)