OUR SERVICES
Whether you’re looking for expert auditing, targeted training, flexible QA/RA coverage, or ongoing strategic partnership, we offer a range of services designed to meet you exactly where you are. Explore the options below to find the solution that best fits your team’s needs, your compliance goals, and the stage of your product’s journey.
Regulatory &
Quality Auditing
Internal audits aligned with ISO 13485, MDSAP, and 21 CFR 4, 11, 210, 211, 820
EU regulatory audits, including EU GMP Part I & II
Compliance assessments against ICH, IPEC, and ISO 14971 risk‑management requirements
Supplier and contract manufacturer audits
Sterilization process audits (EtO, gamma, e‑beam, steam)
Gap analyses and remediation planning
Audit readiness for FDA, notified bodies, and global regulatory authorities
Training &
Capability Development
Customized training on FDA regulations (21 CFR 4/11/210/211/820)
ISO 13485:2016 and MDSAP requirements explained through practical, real‑world examples
EU GMP Part I & II, ICH, IPEC, and ISO 14971 workshops
Sterilization fundamentals and validation expectations
Complaint handling, CAPA, and risk‑mitigation best practices
QMS document creation and training
On‑Demand QA/RA Support
Temporary or fractional QA/RA staffing to fill expertise or capacity gaps
Interim roles such as QA Manager, RA Specialist, or Compliance Lead
Hands‑on support with complaints, investigations, CAPA, risk mitigation, and QMS document creation
Assistance with sterilization documentation, validations, and regulatory expectations
Flexible hourly, project‑based, or short‑term engagement models
Retainer‑Based Consulting
Guaranteed access to senior QA/RA experts for ongoing guidance
Monthly or quarterly support packages tailored to your operational needs
Proactive compliance monitoring across ISO 13485, MDSAP, FDA, EU GMP, ICH, IPEC, and ISO 14971
Ideal for startups, small teams, or organizations without full‑time QA/RA staff