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Contract & Compliance Services

Adjility provides contract & compliance consulting services for a range of clients and business needs. Examples of compliance & contract services include:

Compliance Consulting

Adjility provides services to support compliance initiatives, including:

  • IT Security and Audit Controls (Sarbanes-Oxley, et. al.)
  • SOP Compliance & Reviews
  • Regulatory Paperwork & Reporting
  • Quality Compliance
  • Compliance Audits & Corrective Action Tracking

Contract Consulting

Adjility provides services to support "Contract Excellence", including consulting across:

  • Contract Strategy & Processes
  • Contract Compliance & Administration Monitoring
  • Contract Operations Improvement & Contract

Sample Compliance Services - Pharmaceutical

Pharmaceutical companies have been under increased scrutiny since a few commercialized blockbuster proved to be unsafe for consumers. Medicare drug reform is also applying pricing pressure thus changing the competitive landscape. Additionally, Regulatory Agencies are encouraging industry players to use more technology thus creating new compliance risk.

Given these challenges, Adjility Consulting offers a variety of Regulatory Compliance services that span across each function of the healthcare value chain. For example, for FDA Compliance.

  • Corporate Compliance Strategy
  • Quality Systems Development
  • Compliance Assessment and Remediation
  • Computer Systems Validation
  • Complaint Management Strategy and Development
  • Development of CAPA Program
  • Integration of Compliance Systems
  • Regulatory Compliance Training

Why Partner with Adjility for FDA Compliance?

Adjility believes that Regulatory Compliance should be viewed as a competitive advantage rather than a cost. Our approach places a special focus on the following:

  • A clearly defined Validation Governance Model - Identifying roles and responsibilities early on is key to ensure strong collaboration between sponsors, stakeholders, and team members
  • Implementation of a single, comprehensive Quality System - All existing policies and procedures are reviewed to determine which ones need to be modified and/or created based on project scope
  • A carefully devised risk-based approach - Standards for consistent risk assessment are developed across all processes
  • Part 11 Compliance - Applicable electronic records and signatures are identified based on the predicate rules, criticality of the process, and risk to product safety
  • Strict System Change Control Procedures - A standardized approach is put in place to ensure all changes are assessed for applicable regulation impact

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