Subject Matter Experts

Accorto Regulatory Solutions offers the most experienced SMEs to support your company’s product. Not only do we have a robust in-house team of experienced industry-leaders dedicated to your company’s project needs, but also a network of some of the nation’s leading researchers, project managers, and regulatory specialists ready and eager to aid in these efforts. No matter the project or regulatory challenge, you’ll know you’ll always have the best people for the job.

Clinical Trial Services

Our team collaborates with industry leading Clinical Research Organizations (CROs) to offer robust clinical trials and regulatory medical writing and services. To facilitate this, we perform in-depth studies on subjects and updated literature review research. Currently, our studies are focused on the following:

• Abuse and Liability Assessment studies
• Pharmacokinetics studies
• Biomarker studies

Non-Clinical Services

BRS collaborates with industry leading Clinical Research Organizations (CROs) to provide comprehensive toxicological screening and analysis of products. From study design to data analysis, our experts are ready to develop an evidence-based toxicological testing strategy that simply communicates a product’s characteristics to regulators. Our team has extensive non-clinical experience conducting constituent testing to support premarket submissions to regulatory agencies. These studies include:

• Analysis of constituents, including Harmful and Potentially Harmful Constituents (HPHCs) and other toxicants that may be found in the product.
• In vitro toxicology studies, including genotoxicity and cytotoxicity-based studies such as (but not limited to):

• • Ames assays
  • Micronucleus assay
  • Neutral Red Uptake (NRU) assay

Our toxicological testing strategy reduces the uncertainty associated with the nonclinical screening of the product by employing a battery of internationally recognized in vitro assays. Our extensive nonclinical experience and efficient selection of assays greatly reduces the chance of obtaining false negative or false positive results associated with a single method and is inspired by pharmaceutical industry principles and guidance.

Focused on both service and scientific excellence, we continually track the evolving regulatory landscape to offer relevant and forward-looking constituent testing guidance to our clients. Our experts recognize that each product’s constituent data fits within an overall in vitro and in vivo toxicology strategy and seek to seamlessly integrate constituent data with the complete narrative of a regulatory submission. Regardless of an organizations size or the position of the product within its regulatory lifecycle, our team will produce a customized, resource-maximizing, and comprehensive constituent testing strategy that achieves the client’s regulatory objectives.

Chemistry, Manufacturing, and Controls Services

To help ensure that appropriate regulatory compliance standards are being met, Chemistry, Manufacturing, and Controls (CMC) are used to assess, analyze, and evaluate each product from creation to marketing. In combination with highly experienced scientists, researchers, and regulatory writers, our team has contracted with several global Clinical Research Organizations (CROs) in the production and quality control of various e-liquids and devices. This includes the incorporation/evaluation of the following:

• Flow chart creation/utilization
• Facility processes
• Product sterilization processes
• Validation approaches
• Validation criteria/results
• Certificates of Analysis (CoA) involved in the manufacturing processes
• All process failure modes and effect analysis with the respective mitigation strategies

Our team recognizes the importance of properly executed CMCs. Our experts will assure that the following items are utilizing compliant CMC standards:

• Manufacturing
• Packaging
• Storage
• Distribution of the finished products
• Product composition
• Raw materials
• Equipment used for in-process controls
• Product specifications
• All analytical methods/equipment parameters testing performed on the ingredients that are used in production
• Design control steps
• Safety testing of the devices

Consumer Research Studies

Our experienced team of behavioral scientists developed a comprehensive consumer research and marketing program specifically for regulated products. Our research program leverages leading qualitative and quantitative methods to align completely with current FDA guidance. We provide:

• Perceptions and Intents research programs for regulated product applications
• Market research services for product development
• Marketing plan guidance and development
• Human Factors and Usability testing for product development and regulation

Shelf Life and Stability Testing

Our team of regulatory experts are able to develop and execute shelf-life and stability testing for your specific products across a variety of regulated industries. Drawing from our team’s extensive experience in pharmaceuticals, cosmetics, nicotine, and CBD products, our team will assemble a comprehensive plan based on the critical specifications and unique attributes of your product and its container closure system.