We can help organizations prepare for and successfully navigate BIMO audits. They can provide guidance on what to expect during an audit and offer suggestions on effectively demonstrating compliance with BIMO regulations. This can include providing advice on effectively implementing quality management systems and developing robust internal processes to ensure ongoing compliance with BIMO regulations. Additionally, former FDA inspectors may be able to provide insight into common areas of non-compliance and help organizations identify and address any potential issues before an audit occurs.

Members of exFDA Consultants directly assessed hundreds if not thousands of CSRs. As a result, we are familiar with what regulatory authorities critically examine and how to discern the differences between harmonized and regional requirements. In cases where you have been issued a warning letter or 483, we are versed in interpreting US federal law back into ICH requirements, which allows us to clearly describe the solutions for quick and efficient remediation. Post-FDA employment, our members have successfully drafted CSR submissions to regulatory authorities of the USA and across Europe.

The Trial Master File (TMF) of a clinical study is a compilation of essential documents, both trial-specific and non-trial specific that allows for the seamless reconstruction of clinical development activities. When TMF are pulled, regulatory officials will first look for what we call in the industry, “low-lying fruit.” These are the most common errors and will create an opening for the regulators to dig deeper or expand the scope of their operations. We are familiar with what regulatory authorities prioritize and critically examine as we were once in their shoes, allowing you to continue your study and support your intended claims.

As we have issued many 483s, we will first guide communications to give your organization time to remediate and respond correctly. Your initial response will be judged. If a red flag is raised, the Agency will further scrutinize your organization and request more documentation from additional areas of your technical files. We will help you avoid this if possible. Once a proper response is received, we will work with you to implement satisfactory Corrective Actions and Preventative Actions (CAPAs) to meet regulatory requirements. We can support you throughout the whole process until your organization is up and running again. If desired, we will also equip and train your team to ensure the violation or similar risks will never be repeated.

Former FDA investigators can help with submissions by providing guidance and advice on how to prepare and submit regulatory documents and information for:

• Biologics License Applications (BLA)

• De Novo

• Investigation Device Exemption (IDE)

• Investigational New Drug (IND)

• New Drug Application (NDA/ANDA)

• Premarket Approval (PMA)

• Premarket Notification (510k)

• Q-Submissions (Q-Subs)

We will immediately assess the risk the warning letter brings to your operation and guide you to efficiently “close out” the observed violation. We will work with you to produce the correct proof required and, if required, assist during a follow-up inspection to receive your close-out letter. This applies to the main types of warning letters:

• General FDA Warning Letters

• Tobacco Retail Warning Letters

• Drug Marketing and Advertising Warning Letters

• Untitled Letters to Pharmaceutical Companies

At exFDA Consultants, we specialize in gap analyses for various clinical research quality systems, from sponsor systems to investigator sites, CROs, and laboratories. Our approach is systematic, utilizing at its core ICH E6(R2) guidelines, US FDA 21 CFR 312 and 812 regulations, in addition to their supporting regulations and guidelines, and focusing on people, their skills, training, processes, project management, facilities, resources and equipment.

The core principles remain the same whether it is GMP, GCP, GLP, or even GDP. When FDA investigators examine a quality management system (QMS) during an audit, they must recognize good practices across all spectrums of design & development, manufacturing, and quality assurance.

However, these areas of good practice will require a degree of knowledge or direct experience in a given field. We will not only prioritize what is to be critically examined but ensure your system is, in fact, compliant from its foundation up.

If you are unsure you require a recall, we can help assess the situation and provide guidance. We can assess your situation and guide your next steps swiftly while keeping you compliant, which may very well mean, keeping out of a courtroom in case of:

• Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

• Class II recall: a situation in which the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

• Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

• Market withdrawal: occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.

• Medical device safety alert: issued when a medical device may present an unreasonable risk of substantial harm. In some cases, these situations also are considered recalls.

Quality Management System is a systematic approach to ensure that a company's products and services meet the appropriate quality standards. A QMS typically includes the policies, procedures, and processes that a company uses to manage and improve the quality of its products. Medical Device Single Audit Program, allows medical device manufacturers to undergo a single audit that satisfies the requirements of multiple regulatory agencies, (including FDA) in the United States, Australia, Brazil, Canada, and Japan. By participating in MDSAP, medical device manufacturers can demonstrate that their quality management systems comply with the relevant regulations and standards and can reduce the burden of undergoing multiple separate audits by different regulatory agencies.