For the past 28 years, The Weinberg Group has helped clients maintain compliance, providing a full range of cGMP, cGCP, cGLP,PV audits and SOP development, quality assessments, mock FDA inspections, risk assessment and ISO 13485.
We conduct cGMP audits worldwide and are often called upon to assess and remediate the most difficult manufacturing compliance issues. Whether the issue is with sanitation, labeling, validation, SOPs, training, manufacturing records, aseptic processing, product adulteration, raw materials storage, risk management or other quality issues, we provide the regulatory and manufacturing expertise required to help our clients prevail.
Over the past few years, our GCP auditing services have grown as our abilities and the quality of our audits are recognized among industry executives. Our auditors and managers are seasoned professionals, many with advanced degrees and each with a minimum of ten years GCP auditing experience. They are the best in the business.
We are not a CRO and therefore are able to provide totally independent clinical assessments. Our consistency in audit reporting, high-level analyses, use of local audit talent, 100% QC, and competitive pricing are just a few of the hallmarks that appeal to our clients, especially for urgent or for-cause audits.
We assist companies at all levels on the spectrum of compliance. As you can see below, for clients at the top of their game, we provide auditing, quality assessments, risk analysis and SOP writing, etc. On the opposite end of the spectrum, we are often asked by legal counsel to assist companies who have responded inadequately to FDA admonitions. For these clients, we mobilize and work hard to restore them to full FDA compliance.
