Experience

SUMMARY

Our Team has accumulated over 26 years of experience in operational and quality systems for the industry and is summarized below:

Multi-national regulations, compliance and quality systems:
- QSR Part 820
- ISO 13485
- PMDA
- MDD 93/42 and 98/79
Clinical trials: IDE (Part 812), Conducting clinical trials-CFR Parts 814,50,54 and 56, MDD 90/385
Design control: Design history files/technical files/human factors engineering
Regulatory filings/reports:
510k/PMA
Canada MDL
Japan PAL/MAH
EU CE marking/Conformity
CLIA-diagnostic/testing lab
Annual reports- Class III
PMA supplements/amendments
Inspections and audits: government agencies, notified bodies, third parties, and remediation activities
QA/Regulatory oversight of the design, manufacturing and labeling of devices, with particular expertise in the following categories:
- Infusion Pumps-Class II
- Dental Devices- Class II and III
- Plasma/Blood- Class II and III
- Regulators/Ambulatory pumps- Class II
- Enteral Nutritional Devices- Class II
- Blood banking/tracking software- Class II
- IVDD (devices)- Class II
- Single use devices (SUDs)

Multi-national regulations, compliance and quality systems:
- CFR Parts 58, 210/211 and 600
- ICH Q7, Q8, Q9 and Q10
QA oversight of Clinical Trials/CRO and Clinical Trial Material: CFR Parts 50,54,56 and 312, ICH E6
Regulatory filings/reports:
- CMC for ANDA and NDA
- DMFs- US
- ASMFs- EU
- Annual Report/Annual Product Quality Reviews
- CBE supplement- prior approval and 30 day
- BLA
Inspections and audits: government agencies, third parties, and remediation activities
QA/Regulatory oversight of the manufacturing and labeling of drug/biologic products with particular expertise in the following categories:
- Plasma/Blood components and Factors
- Vaccines
- Oral products- OTC and prescription
- Topical- prescription creams and ointments
- Parenteral products:
  - Antibiotics
  - Anesthesia
  - Cardiology
  - CNS