Veracord
Consulting Services for the
Life Science Industry

Why Choose Us

Veracord is a complete provider of consulting solutions to the Life Science Industry: Pharmaceutical, Biotechnology, and Medical Device companies. We apply established industry best practices gained through extensive experience across multiple industry sectors to deliver Regulatory Compliance Solutions that are prudent and scalable for emerging companies to Fortune 100 clients.

Organizations face greater regulatory scrutiny than ever before because the data used to make clinical and regulatory decisions absolutely must be trustworthy. In the USA, the Food and Drug Administration (FDA) and other regulatory bodies require that electronic systems used for regulated purposes undergo validation and remain under change control. Companies with global operations take on additional regulatory challenges, given their need to consider varying regulatory environments and cultures with different generally acceptable business practices.

Because of the heightened risks associated with noncompliance, executive management and boards are under increased scrutiny — not only from regulators, but also from customers, clients, stockholders, and business partners — to ensure internal controls are in place to address compliance with laws and regulations. In response, many organizations are taking an integrated approach to implementing a regulatory compliance framework, which involves developing and establishing a compliance methodology, policies, procedures, and a training program. Regulatory Compliance leads to a variety of benefits, including corporate oversight and guidance for compliance activities, improved efficiencies and effectiveness, increased employee awareness of regulatory compliance requirements and issues, and reduced legal, reputational, or financial risks.

68

Quality Systems Projects

347

Successful Projects

106

Audited Systems

1784

Systems Validated

3982

Validation Documents Generated

117

Happy Customers

Our Process

Our Client Engagement Process ensures that we quickly learn what's important to you, so we work efficiently to achieve agreed upon tangible benefits for you.

Step 1
Discovery

Our client engagement process always seeks first to understand our clients, and with you, commit to solution-oriented engagement, which typically begins with a Gap analysis.

Step 2
Present

Taking the results of the Gap Analysis, we then seek to "be understood." We share our findings and then, working with you, develop a prudent plan for implementing required changes.

Step 3
Implement

This is the action step, and includes Corrective Action in the form of our staff working with you on-site to remediate defincies in your Quality System and Validation Program, and also often includes Training and Compliance Management.

Step 4
Review and Maintain

Compliance is an ongoing effort. As small companies grow, their Quality Systems and Validation practices must grow. Further, as global regulations change, companies must update their compliance programs to meet the changes.

Our Competencies

Veracord is a complete provider of consulting solutions to the Life Science Industry: Pharmaceutical, Biotechnology, and Medical Device companies. We apply established industry best practices gained through extensive experience across multiple industry sectors to deliver Regulatory Compliance Solutions that are prudent and scalable for emerging companies to Fortune 100 clients.

Validation Services

From validation audits to program assessment and development, Veracord has the staff and experience needed to meet your validation needs.

GxP Audits & Remediation

Whether it's internal or external, vendor or supplier, Veracord provides audit and remediation services on a global basis.

Compliance Services

Veracord leverages your existing practices, policies and procedures to develop quality systems that are efficient, effective, and compliant.

Clinical Services

From project planning to study management, operational support, or data management and analysis, Veracord provides the clinical specialists you need.

Medical Device

We begin by understanding your compliance needs, and provide flexible medical device regulatory and compliance throughout the product life cycle.

Project Services

Veracord works with you to support your turnkey project requirements, from onsite project based solutions to staff augmentation.