A robust compliance framework is vital to any GxP organization. Our compliance consulting practice develops compliance frameworks for GMP, GLP or GCP organizations. We assist our clients in implementing and evaluating specific programs. Another area of our expertise is developing master plans for new facilities and expansion projects.

Our services are focused on both the strategic and operational concerns involved in helping companies meet an increasing number of compliance requirements and the related control issues surrounding business risk management.

Our auditing practice engages in evaluating or implementing compliance and quality assurance programs within existing facilities. The audit team performs vendor audits to evaluate software application vendors.

Kinship Services maintains its own corporate Standard Operating Procedures (SOPs) which govern all critical operations in trial management, data management, biostatistics, and clinical research report writing. These SOPs comply with all industry regulations set by TPD, FDA and ICH. Project-specific SOPs are generated as required.

They form part of the project documentation and are an important element in the ongoing review process for our corporate SOPs. Both our EDC solution and our internal IT environment have been designed to meet the regulatory requirements set forth by FDA 21 CFR Part 11 and FDA Guidance for Computerized Systems Used in Clinical Trials.

Kinship Regulatory Compliance offering are categorized into

21CFR Part 11 Practice

GxP Auditing and Implementing of compliance programs

GMP/GLP/GCP Validation Practice

Audit Vendors