Quality Control Method Development & Validation
Unlike traditional FDA IND processes, the IND process for botanical drugs presents a distinctive quality control challenge. ABDA Analytic, renowned for its decade-long establishment of the botanical product reference bank, stands out as one of the leading botanical product research analytic laboratories in the world. With state-of-the-art technology and specialized expertise in botanical product research, the Analytic Lab stands ready to craft a customized solution tailored to fulfill your product-specific quality control requirements.
Upon receipt of drug product samples, the Analytic Lab formulates tailored methodologies to generate HPLC fingerprints. Subsequently, the Analytic Lab conducts validation of the methods. Once the methods are validated and deemed stable, both the methods and the HPLC fingerprints are provided to customers.
Centered on our FDA botanical drug IND expertise, leveraging extensive knowledge in botanical medicines, established research collaborations with world-class institutes specializing in botanical medicines, alliance with several botanical Contract Development and Manufacturing Organization (CDMO), ABDA engages in collaborates with organizations such as yours to propel the development of botanical drug products within the FDA's regulatory framework for botanical drug INDs:
Conducting market research to guide the selection of the most promising botanical product candidates and their IND indications
Reviewing existing information and data to formulate an efficient approach to the IND pathway
Developing and validating quality control methods tailored to specific drug products
Transferring quality control methods the botanical CDMO servic companies and guiding the manufacturing of drug productions intended for clinical trials
Unlike the preclinical development process for single-molecule drugs, the preparation of drug products comprising a blend of botanicals is notably more complex. Although the particular ingredients and indications may differ among various IND applications, all preclinical studies for botanical drugs adhere to a shared blueprint for achieving success:
Qualification and quantification of ingredients in a botanical drug product
Establishment of quality control mechanism for a botanical drug product
Identification of unknown ingredients in a botanical drug product
Quantification of known ingredients in a botanical drug product
In-vitro study for a botanical drug product with multiple ingredients
In-vivo study for a botanical drug product with multiple ingredients
Pre-clinical pharmacokinetics study for a botanical drug product with multiple ingredients
Dose-response study for a botanical drug product with multiple ingredients
FDA Botanical Drug IND Package Development
ABDA expert team follows a structured process to support the development of your botanical drugs INDs:
1. Review of Raw Materials: We conduct a thorough assessment of the raw materials involved in your botanical drug product. This step ensures that all components are in compliance with FDA regulations and guidelines.
2. Content Collection: Our experts gather and compile all the necessary content required for the Investigational New Drug (IND) packet. This includes data on ingredients, quality control, safety, efficacy, and other essential information.
3. IND Packet Development: ABDA's team uses the collected data to create a comprehensive IND packet that aligns with FDA requirements. This packet serves as a foundational document for your botanical drug development process.
4. Submission to FDA: We submit the IND packet to the FDA on your behalf. This step ensures that all required documentation is properly presented to the regulatory agency.
5. FDA Meeting Coordination: participate in meetings with the FDA for discussions related to botanical drug development. These meetings provide an opportunity to address any questions or concerns and seek clarification on FDA expectations.
6. Interpretation of FDA Decision: Upon receiving feedback from the FDA, our experts interpret the FDA decision letter, helping you understand the agency's feedback and recommendations. This interpretation is crucial for making informed decisions on the next steps in drug development process.
ABDA's proficiency in guiding the FDA Botanical Drug Development process simplifies the journey of developing botanical drugs, ensuring alignment with FDA guidelines and increasing the probability of securing successful regulatory approval.