You are here: Home Services Integrated Development Support Scientific & Regulatory Reporting

Scientific & Regulatory Reporting

From the initial regulatory approval to the end of your development, you will require regulatory compliant documentation. But it does not end there! You will need to show that your project is secure and needs development. PhinC can help you to rise to this challenge.

Regulatory Submissions

With many years of experience in the field, PhinC can help you to assemble your IND (Investigational New Drug) Dossier for the US authorities and/or IMPD (Investigational Medicinal Product Dossier) for the European authorities, as well as your Investigator Brochure & Maintenance (eCTD format).

Those documents must reflect the relevance and reliability of your research, with particular emphasis on a clear strategy, informed decisions and substantial results. We support you during agency meetings in order to answer questions from the health authorities.

Clinical Trial Support

Barrier and stairs

In order to ensure efficient clinical trial management, PhinC is able to write your study protocol in accordance with the relevant regulations and Information Consent Forms (ICF). To advance further and reveal substantial information, PhinC can compile statistical and pharmacokinetic reports and Clinical Study Reports (CSR).

We also liaise with the CROs, taking care of the Monitoring Plan, DMP (Data Management Plan) and SAP (Statistical Analysis Plan).

Due Diligence Process

So, you have decided to carry out due diligence on your product? PhinC can help you to effectively persuade your representative by:

Formulating comprehensive scientific documents to demonstrate all the clinical interests related to your compound,

Integrating all important documents involving study data (safety and efficacy reports, development plans, etc.)

Preparing and supporting you during due diligence auditing.