Service Introduction

Centreing on the consistency evaluation of generic drugs and the research of new drugs, Titanium Pharmaceutical provides professional services in the quality research of APIs, solid preparations, and injections. It is based on compliance with global drug regulations and data integrity, professional skills and perfect quality system, and customer-oriented, in order to win customers' trust, improve the quality of medicines, and do our best for human health!

Service Content

Complete service for API quality research

Complete service for preparation quality research

Assessment and testing services for genotoxic impurities residues

Assessment and testing services for elemental impurities

Structure analysis and impurity mass spectrometry of unknown impurities

New drug compound quality research service

Inspection and testing service

Import and export registration and declaration service

Service Features

It owns both CMA and CNAS qualifications, combines with the quality assurance system implemented by GMP requirements, and has passed multiple on-site inspections by the National Bureau and other institutions

It owns advanced laboratory equipment and a network version of the mass spectrometer workstation to ensure that the test results are accurate, reliable and traceable

It owns an experienced technical team, strictly follows CDE and ICH related guidelines to ensure compliance with implementation regulations

The report is under a lifelong responsibility system

Service Process
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Customer consultation: Quality research and declared project consultation

Information survey and project evaluation: The client prepares a compatibility information survey form, and evaluates the resource allocation (personnel arrangement, material preparation) required to complete the task on time according to customer needs and actual conditions

Confirm the quotation and communicate the preliminary plan: Design the preliminary test plan (including stability test) as required by the client, and confirm the quotation

Signing contract

Material handover and project allocation: The client prepares the samples, standard products and their COA, MSDS required for the project, and delivers the samples, standard products and their COA, MSDS to the sample manager for sample collection and storage; the test unit assigns the project leader, QA and experimenter

Project plan and schedule determination: The project leader designs the plan and schedule plan according to project requirements, and submits them to the quality assurance department and the client for review and confirmation

Test development (inspection and progress control): the project leader will conduct formal tests after approving the project plan; the quality assurance department inspects the project process, and the project management department supervises the project progress

Data confirmation, report preparation, review and approval: The project leader reviews the nuclear test data, prepares the draft report, and submits it to the quality assurance department and the client for review

Issuing the final report (publish articles and receipt by the customer): The project leader signs and issues the final report, and the client ends the project. The original data and a final report are archived in the company.

Online Service Consultation
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