At ChalPharm, we have extensive experience with analytical methods and can review analytical procedures to ensure that methods are appropriate for their intended purpose.
We can establish new analytical methods or develop existing methods. This can be carried out at the client’s site or developed in partnership with external contract research organisations. Being independent, ChalPharm can select CROs who can provide the highest quality service for the particular application.
ChalPharm can assist with any stage of analytical method validation. From a top-level review of planned validation protocols, data or reports, to full management of the validation process, we can help you to avoid the pitfalls and ensure compliance with the appropriate regulatory guidelines.
We can provide advice on pharmacopoeial requirements and test methods and arrange for analysis to be carried out to meet your needs.
ChalPharm can free up your valuable resources by managing a range of analytical services. We will continuously monitor the analytical results and immediately flag any untoward results. Reports will be compiled in accordance with your requirements.
We have expert knowledge of chiral analysis and all aspects of stereochemistry. ChalPharm can propose chiral analysis strategies that are cost and time-effective, which fulfil the relevant regulatory requirements. In conjunction with CROs and associates, we can provide a resolution service tailored to your needs.
Comprehensive characterisation of the drug substance is a fundamental part of any regulatory submission. ChalPharm can work with you to compile a complete characterisation package.
We can advise on the characterisation of polymorphs. In association with specialist service providers, we can recommend cost effective solutions to polymorphism issues.
ChalPharm can review your existing stability studies, assist with designing new studies, or help to write stability study protocols in compliance with ICH guidelines.
Based on the data from stability studies, ChalPharm can work with you to prepare a comprehensive stability report and to set the shelf life for your drug substance or product.
We have extensive experience in transferring analytical methods. ChalPharm can assist with the creation of a method transfer project plan. This defines the scope and time-scale of the project and is a useful document to ensure that all interested parties are aware of the impact of the transfer and have ‘bought into’ all aspects of it.
We can also assist in the preparation of a method transfer plan – a top-level document to define strategy. This identifies which methods will be the subject of a formal method transfer. Considerable cost savings can be achieved if not performing a formal transfer of other methods and therefore justifications for these will be included in the method transfer plan as appropriate.
ChalPharm can help with the preparation of method transfer protocols. These documents are essential for securing the necessary framework for successful QA approval and to avoid ambiguity between the originating and receiving laboratories.
We can review existing data that is to be used as a platform for transfer and we can provide expert recommendation of acceptance limits based on available data.
ChalPharm can review your analytical data and, taking into account any regulatory guidelines, advise on specifications that should be set for your drug substance, product or any starting material or intermediate.
We have considerable experience in the preparation of CMC sections of documents for submission to regulatory authorities. We are able to compile CMC sections, or we can review your documents and advise on any areas that may require revision before submission to the regulators.
We have experience in handling high potency compounds and can advise on analytical strategies that minimise risk.