Available Consulting Services from BDRC
regulatory & quality advice
If you have a difficult regulatory or quality problem concerning the use of an excipient or food/color additive in a pharmaceutical, dietary supplement or food product for a specific target market or you want to introduce a new ingredient into that market, expert advice can be provided to minimize any regulatory hurdles that might occur so that your product can launch ON-TIME! If you manufacture an excipient, food additive, color additive or dietary ingredient, advice can also be provided by BDRC to improve your operations and quality programs to meet your customer’s expectations and enhance your bottom line. Even if you have your own regulatory resources internally, BDRC can provide an independent, outside opinion on an issue which can be useful.
supplier qualification
Regulators around the world are expecting that pharmaceutical, dietary supplement and food companies fully qualify their ingredient suppliers and a number of companies have received warning letters and other citations due to not adequately qualifying their suppliers and contract manufacturers. This is a growing problem! Assistance can be provided by BDRC to design, develop or enhance your supplier qualification programs so that they will meet the ever-increasing expectations of regulators. This can involve third-party assessment of your existing qualification processes or direct involvement with your suppliers to enhance their GMP systems by providing third-party audits and recommendations for improvement.
quality by design
Successful products in the market today must be designed to address variability in both the product’s own manufacturing process and in the ingredients that are used. Ingredient variability has not historically been adequately investigated and understood until product failures trigger detailed research into the cause of the problems. Regulators are now expecting that Quality by Design (QbD) be built into pharmaceutical and food products to prevent failures and problems which could impact consumer/patient safety. BDRC can assist with QbD assessments of the impact of ingredient variability on your products and can provide recommendations for the development of robust products and formulations which will be less impacted by this variability.
market expansion & commercialization
Assistance can be provided to help excipient and food/color additive manufacturers and distributors introduce new products and expand their markets for existing products globally. Identification of key regulatory/compendial compliance requirements for the target countries can be provided by BRDC and action plans can be developed to facilitate the use of these products in target markets and provide your customers with the assurances they need to decide to incorporate your products into their development and product improvement projects. Help with the introduction of novel excipients, new food additives or new color additives in various countries can be provided.
compliance & audit assessments
GMP Audits are an essential part of any good Quality program and company audit resources are many times limited. Therefore, internal audit resources must typically focus just on the key priority internal processes and on key ingredient suppliers. However, global regulators expect physical audit information to be part of all supplier or contract manufacturer qualification risk assessments. Therefore, third-party audit assessments and certification programs are typically needed to cover all of your ingredient suppliers and contract manufacturers. BDRC can provide qualified third-party GMP audits and corrective action plans to support your risk assessments and quality improvement projects.
Start up business assistance
If you are a chemical company who may think that you have a material which could be used in the pharmaceutical, dietary supplement or food industry, but you currently do not operate in these regulated industries, it is important to understand all the regulatory and customer requirements that will apply if you decide to market your products for these applications. BDRC can help you with advice and training for your management and employees about what GMP, quality systems and technical information you will need to have in place. BDRC can also provide audits/assessments of your operation to determine what additional systems, procedures or technical support you may need to develop to compete in the targeted regulated industries.
Registration dossier development
Depending on the type of product you want to sell in a given target market, various registration documents may been needed to gain appropriate approvals such as Drug Master Files (DMFs), food or color additive petitions, GRAS affirmations, dietary ingredient notifications or similar documents. In China, you will need to register any of your excipient products you want to sell and submit a detailed dossier for assessment by CDE during the joint review of your customer’s drug application. Advice can be provided by BDRC to companies who want to develop and submit these types of documents to regulators. (See the China Services page for details on the China Services BDRC can provide).
regulatory and quality training
BRDC is actively involved in many current regulatory and quality programs through various trade associations which means that updated information can be shared on the current status of many important initiatives coming from global regulators and compendia. BDRC can provide training programs on many hot topics as well as various fundamental areas of excipient, food/color additive regulations that may impact your company. This type of training can be provided to both industry and regulatory personnel who may need to keep up to date with current activities related to these type of ingredients. Training can vary from a simple presentation to a full multi-day course depending on the level of training needed.
other services
BDRC has significant expertise related to excipients, food/color additives and non-dietary ingredients and there are many additional services that can be provided. Additionally, BDRC has set up relationships with a number of other consultants who, as a sub-contractor, can offer additional expertise when needed for a given project. If you have a need for help or training with anything related to ingredients for drugs, dietary supplements and foods, please let BDRC know and we can discuss the scope of what you may need. Fill out a project request on the BDRC Home Page and we can get started!