Compliance Consultancy
Staying compliant with regulations is essential for any company operating in the healthcare industry. Our compliance consultants provide guidance on a range of compliance issues, including data integrity, product labeling, and pharmacovigilance.
Audits
o Medical Devices
● ISO13485 (QMS) /GXP Audits
● FDA mock inspections
o Drugs & Biologics
● ISO 9001:2018 (QMS)/ 21 CFR 211 /GXP Audits
● FDA Mock Inspections
● Health Canada audit
Regulatory Remediation
o Medical Devices
▪ Audit readiness
▪ Consent Decree
▪ Warning letters
o Drugs & Biologicals
▪ Audit readiness
▪ Consent Decree
▪ Warning letters