Our Services
Drug Substance Synthetic route design and improvement
Develop and execute the phase-appropriated synthetic route to support drug substance manufacturing.
Drug Substance Scale-up
Scale-up is a combination design of chemistry and engineering. Lack of scale-up has delayed many projects moving forward to the late phase stage.
Regulatory Starting Materials Selection and Justification.
Impurities fate and purge study plays a key role in the regulatory starting materials (RSM) selection and justification.
PPQ enabling and execution
PPQ enabling and execution is the first step of entering into the commercial stage.
Analytical Development
Developing and executing the phase-appropriated analytical methods are the key milestones for providing data for decision-making. It also helps to establish the control strategies for drug substances and drug products.
Stability Management
Manage the stabilit y programs of drug substance and drug product, and propose the storage conditions and shelf life projection using statistical tools (JMP) per ICH Q1E.
Method Validation and transfer
Phase appropriated method validation and suitable transfer strategies help to significantly reduce the project time and secure the supply chain, especially when you establish the 2nd supplier without interrupting the relationship with the first one.
Module 3 Preparation
Our team members have strong experiences with (Module 3) CMC sections. Many of our submissions have no agency questions before approvals.
CDMO Management
More and more companies choose CDMO as their research and manufacturing partners. Managing them timely, interacting with them properly and getting the best resources can significantly shorten the project timeline with quality work.
Quality Audit
Compliance status is one-vote veto to obtain product approval or maintain manufacturing licenses. A well-prepared mock audit can help our clients to identify the gaps and correct them before the agency comes.
GLP and GMP SOP preparation
Our team members have prepared the SOPs for our clients in US, EU, and China to establish their GLP and GMP systems, covering QA (or QAU), Lab procedures, computer data systems, facilities and instrument management, training system, and many other general policies.
Packaging and shipping validation per USP <1079> and ASTM D4169
Shipping validation becomes critical for cold-chain management during product development. Designing good packaging and validation strategies helps deliver the products safely to the final destinations.
US Agent
All the oversea companies are required to have their US agents for FDA regulatory affairs.
iPSC Cultrure and genetic modifications.
Describe one of your services
Our Experiences
Here are some remarkable projects in which our team members executed with the clients.
01
Method Validation
Our team member led the project and finished 120+ complete validations within six months to support the PPD production before the NDA submission.
02
GLUCAGON BIOIDENTITY TESTS per USP <123> and USP <111>
Only several labs worldwide can perform the Glucagon bioidentity Test per USP <123> and USP <111>. No commercial statistical software can analyze the parallel-line assay data since either the low- or high-dose level, but not both, may be excluded from the calculation to meet linearity requirements. Our team member designed and validated an Excel template to perform the parallel-line assay data analysis and use it for QC testing.
03
Module 3 (CMC) Preparation
The CMC section (module 3) of IND and the quality section of IMPD drafted by our team members have NO information requests from FDA and EU agencies for a Phase 2 project. Our team members have submitted 15+ NDA, IND, IMPD, BLA, and ANDA submissions to the FDA and other agencies.
04
Shelf Life Projection
In the early phase, the clinical testing materials usually have minimal stability data to support a suitable shelf life. Our team members used a risk-based approach (FMEA) and the statistical tools (ICH Q1E) to extend the shelf-life of a phase 1 drug product and accepted by regulatory agencies.
05
Using DOE to support QbD in the generic drug product development.
Design of Experiments (DoE) is the most efficient tool for understanding the critical process parameters and supporting quality-by-design (QbD) based submission. Our team member used the DoE to develop an injectable drug product and achieved better process control. This project received FDA approval within 10 months without any information request.
06
SOP Preparation
Our team members have helped our clients from the US, EU, and China to establish the quality system and in-house procedures. These quality systems included GLP and GMP, from general policies to lab procedures. Our clients have gone through several establishment inspection, as well as the GMP and pre-approval inspections.
