SERVICES
Regulatory Affairs
We are a premier provider of regulatory affairs, pharmacovigilance, dossier preparation, quality assurance and training services.
From Gap Analysis to Dossier Development
Our company specializes in providing a comprehensive Dossier Gap Analysis service, aimed at evaluating your existing dossier and aligning it with market requirements. We understand the critical importance of a well-prepared dossier in successful regulatory submissions and market approvals.
Our expert team will conduct a meticulous assessment of your dossier, examining its content, structure, and compliance with regulatory guidelines. Through our in-depth analysis, we identify any gaps or deficiencies that need to be addressed to ensure alignment with market requirements.
CMC writing
Our consultancy excels in providing expert guidance and support for composing and refining key sections of your dossier, including the Non Clinical and Clinical Summaries of Module 2 and the Chemical Manufacturing and Control (CMC) sections of Modules 2 and 3. We merge our robust experience, which spans hands-on work within manufacturing facilities, with our extensive expertise in medical writing across various product categories.
We offer services that go beyond mere compliance; we ensure that your Clinical Study Reports (CSRs), pharmacokinetic/pharmacodynamic (PK/PD) addendums, and the Module 2 summaries and overviews are meticulously crafted to resonate with clarity and precision.
Get in touch with us
At Composite Pharma, we believe in building long-term partnerships with our clients and providing exceptional service at every step of the way.
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