Dossier Preparation & Filing
Any pharmaceutical product intended for patient use goes through the process of reviewing and evaluating the drug dossier, which includes detailed information about administrative, quality, non-clinical and clinical data. For many pharmaceutical companies, the production of dossiers is an expensive, time-consuming and resource-intensive process. The actual process of drug development can be delayed, or even derailed, due to the tedious work involved. From formulation development to product analysis to the final production, dossiers need to be fully considered all the way through each step of the process.
BOC Sciences' global regulatory affairs team can provide CMC file support for your antiviral drug applications in different countries. Our experienced team works with a diverse range of projects to prepare your regulatory dossier through forward-looking gap analysis and careful preparation of source documents. Our team of professionals can add tremendous value to your development program and accelerate time to market.
Our Major Strengths
- A highly skilled regulatory affairs team with an average of approximately 10 years of pharmaceutical industry experience
- In-depth regulatory knowledge of antiviral drugs with a clear internal thorough technical and quality control review process prior to client review
- Our experts have multil-ingual capabilities to help answer questions from regulatory agencies
- Our program and project management staffs are able to coordinate seamlessly across the BOC Sciences platform
Preparation Folder
- Drug Master Files (DMF) compilation for open and closed part, and CTD format of the entire DMF
- Expert reports on quality, preclinical and clinical studies
- Preparation of summary of antiviral drug product characteristics, package inserts, and product rationale.
- Preparation of periodic safety update reports
What We Offer
At BOC Sciences, we have a dedicated dossier preparation team that has been exceeding our clients' expectations for years. We can deliver the following supporting documents:
- Scientific report
We employ a dossier-centric strategy to deliver scientific and technical reports, which means that we end up with dossier submissions that ensure consistency, integrity and readability.
- Drug Products
Drug product formulation development reports
Drug product manufacturing process development reports
Investigation reports
Characterization reports
Criticality assessment reports
Transfer reports
- Drug substance
Criticality analysis report: Quality by Design (QbD) methodology, identification of Critical Quality Attributes (CQA) and Critical Process Parameters (CPP)
Control strategies for drug substance processes
Sources and destinations of impurities during the drug substance process
Regulatory starting materials justification
Registration activity reports
Process development reports
PAR validation reports
- Analytical development
Stability reports
Solubility transfer report
- Quality documentation
We offer a comprehensive range of high quality document writing, production and maintenance services. We provide custom research report writing services, risk assessment reports. In addition, quality document writing services related to materials is also available.
- Regulatory dossier
BOC Sciences has the ability to manage a comprehensive and error-free pharmaceutical dossier service to help structure the submission of registration documents. The experts in our file development team work in parallel with the drug development process to build regulatory files. It is through this standardized approach that we have succeeded in speeding up the process. This gives us greater flexibility and adaptability throughout the process of preparing dossiers.
Why Partner with BOC Sciences?
- We apply our years of proven expertise and experience in antiviral drug development to improve the success of your program
- Our continuously updated facilities support a range of antiviral drug analysis and manufacturing Synthesis & Manufacturing
- BOC Sciences' experienced team of scientists and regulatory staffs are focused on working with our clients to deliver timely and high-quality small molecule antiviral drugs
- Our partnerships with leading experts in emerging technologies allow us to apply innovative solutions to your antiviral drug research programs
※ Please kindly note that our services are for research use only.
