Aside from being a regulatory mandate (e.g., 21 CFR Parts 210, 211, 600 and 610, and 21 CFR Part 820), ensuring  regulatory and quality compliance makes good business sense.   Internal and external (vendor) inspections of operations allow prompt identification of non-compliant practices which may save you valuable time and money in the event critical areas are affected.    Audits conducted early and frequently throughout a development program ensure timely corrective action which reduces total project costs and ensures projects remain on the critical path.

Quality System design and compliance experience:

• Core-level Quality System design, drafting and implementation services encompassing Quality Control and Quality Assurance functions 

  • Corporate and Department-level Policies and Standard Operating Procedures (SOPs) with related record forms)

• Regulatory & Quality compliance auditing, including internal and external (vendor) inspections based upon both domestic and international legal & regulatory requirements:

  • Current Good Manufacturing Practices (cGMP,  21 CFR Parts 210 & 211)
  • Quality System regulations (QSRs (21 CFR Part 820)

• Due Diligence auditing for corporate merger & acquisition or licensing transactions

• SOP & procedure writing; Medical Device Design Creation and Verification; Pharmaceutical Manufacturing Process Validation; Equipment & Facility Installation & Operational Qualifications;

• Analytical Methods Validation;

• Equipment Installation, Operational Qualification and Performance Qualification (IQ, OQ & PQ)