EAS offers the following services to the biologics and biological products industries(including vaccines, blood and blood components), through our comprehensive regulatory consulting services. From the evaluation and implementation of quality assurance programs, FDA Inspection preparation, and compliance remediation, our consultants help firms understand the unique regulatory requirements these products have per the Center for Biologics Evaluation and Research (CBER).
CBER's authority resides in the Public Health Service Act and in specific sections of the Food Drug and Cosmetic Act. EAS independent consultants have a long career history in both industry and federal service, working directly with companies striving to maintain an edge in this competitive marketplace through practice and demonstration of meeting safety standards through Good Manufacturing Practices (GMPs). Our consultants assist with the interpretation of FDA policy and guidance documents related to cGMPs as well as provide valuable assistance in the preparation of SOPs for complaint handling, recalls, change control, ISO Quality Systems, employee practices, and failure investigations. In addition, our expert toxicologists review Chemistry and Manufacturing Control (CMC) submissions to FDA for completeness and accuracy.
EAS auditing services include cGMP, Quality System and pre-approval audits of manufacturers, laboratories and vendors, due diligence for M&A and insurance assessments, as well as “FDA mock inspections” to help firms prepare for FDA pre-approval inspections.
In addition, EAS assists with guidance on import procedures and obtaining clearance of products through U.S. Customs and FDA at time of entry.
EAS provides expert and thorough consulting services to assist you with Good Manufacturing Practices for your biologics products.
If you would like additional information or discuss how EAS can help your firm please contact us!
A product recall is a time-consuming and expensive endeavor but is required whenever a regulated product is found to be either defective or potentially harmful. Whether the recall is voluntary or requested by these agencies, the recalling firm must have a procedure in place to ensure all violative product is removed from the marketplace.
From ingredient/component suppliers to manufacturing /processing/labeling, to the distribution of the products within the U.S. market, firms should take a proactive approach to ensure the safety of their product and reduce the potential for a recall. EAS can assist with the performance of a mock recall to assess your readiness to execute an actual recall.
In the unfortunate event of a recall, EAS consultants can advise on the recall process to ensure compliance and act as a conduit of information between your company and the FDA. or other government agency.
EAS offers import entry assistance for foreign firms whose products are in detention. Our consultants work with FDA and Customs Border Patrol to determine the reason for detention and assist clients in developing and executing a remedy allowing for the expedited release of affected products. Working as a foreign company’s US Agent, EAS offers the best in regulatory solutions for your most pressing import needs.
In the event that FDA issues a 483 or warning letter or the Department of Justice files a consent decree, EAS can assist with a timely and appropriate response. EAS also assists as a third-party expert for review, audit, and evaluation of facilities and documentation, and can formulate a remediation plan and response in compliance with FDA requirements
FDA ensures the quality of biologics products in the US marketplace through a system of Good Manufacturing Practices (GMPs). These GMPs provide a standard by which all companies must operate, from handling raw materials, the safety and security of the facilities to testing and validation of equipment and product which together helps to prevent contamination, mix-ups, deviations, failures, and errors. While GMPs are standardized per each FDA-regulated industry, understanding how to apply GMPs in a biologics manufacturing setting is unique, with specified controls based on scientifically sound design, processing methods, and testing procedures suitable for the unique products and working environments.
EAS consultants offer the best in biologics GMP compliance audits and facilitate an understanding of how to implement quality programs that meet FDA expectations.
EAS is staffed with former FDA investigators and industry auditors that are available to audit firms that are being considered for acquisition or investment or are being considered as a potential contract manufacturer, packager, distributor or testing laboratory. EAS can perform due diligence audits that will assess their current level of compliance with FDA GMPs and other regulations and identify potential quality and regulatory risks and gaps. By having EAS on the due diligence team regulatory and compliance risk can be minimized.
Good Laboratory Practice (GLP) and Current Good Manufacturing Practice (GMP) requirements for laboratories producing biologics products encompass requirements for the laboratory’s physical facility and environment, quality agreements with lab contractors; the accuracy of instrument calibration and maintenance programs; computer systems; samples and sampling schemes; microbiology practices and procedures; lab SOPs and more. The importance of these schemes for obtaining and reporting credible analytical results leading to a safe and effective product is paramount to the supply chain’s success.
EAS consultants are experts in GLP and GMPs and offer review audits of contractor and supplier laboratories to ensure compliance with required components of each. Our assessment reports allow for a complete understanding of all component areas, a GAP analysis and recommendations for improvements to return to standards.