Common Technical Documents/Clinical Expert Statements
• HPM has considerable experience preparing common technical documents (CTD) according to ICH guidelines.

• We write CTDs for new market authorizations, prescription to over-the-counter switches, line extensions, orphan indications and applications for drugs with well-established use.

• Depending on our clients’ needs we can write whole sections or parts of sections, add to existing files, edit, update, proofread and prepare dossiers in paper form or as fully hyperlinked electronic versions (eCTD)

• We can work with clients’ templates and according to their style conventions or we can use our own templates based on ICH guidelines and modify them for late-stage products, OTC-switches, and orphan drugs.

Investigational Medicinal Product Dossier (IMPD)
HPM is experienced in writing this relatively new document which became mandatory in 2004 following the enactment of the EU clinical trial directive and have developed a template for this according to the EMEA guidance.

Investigator Brochure (IB)
At HPM we focus on systematically highlighting the most salient points to ensure that clinical investigators are able to quickly familiarize themselves with all relevant information. We attach considerable importance to the fact that the contents of your IB are tailored to the phase of clinical development your product is in and that it will require frequent updating.

Study protocols and reports
• HPM has extensive experience preparing clinical trial protocols and reports according to International Conference on Harmonization guidelines

• We also prepare study protocols and reports modifed for observational studies.

• Depending on the needs of our clients, we can write from scratch, edit or QC the documents or we may just give conceptional input.

• We also prepare synopses for trial registries which became mandatory for all clinical trials starting after 1 July 2005

Summaries of Product Characteristics (SmPCs), Patient information leaflets (PIL)
• HPM usually prepares SmPCs in parallel with CTDs since both have to be in line with each other.

• Although usually finalized by sponsors, HPM may provide advise and later translate SmPCs into PILs.