CRO Consulting Services

A good plan is work half done

Palleos’ consulting services cover your product's progression from indication-finding to clinical trial, and, eventually, market authorization application.
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CRO Consulting Services

target product profile
summary of the development strategy
assessment of the market situation
manufacturing strategy
clinical development strategy
lifecycle management plan
preclinical development strategy
regulatory strategy
intellectual property (IP)

Drug development

Palleos provides comprehensive, tailored consulting solutions for medical product development based on your requirements and individual challenges. In the course of your product’s development, we continuously remain focused on the product’s core features—its Target Product Profile (TPP)— combining product features and goals for development.

Medical device development​

Palleos provides comprehensive consulting solutions for medical product development, customized to your requirements and challenges.

Throughout development, we maintain focus on the product’s Target Product Profile (TPP), aligning product features with development goals.

Palleos' CRO Consulting Services cover a product's progression in development from indication finding to trial development.

Product Definition

  • Gap analysis
  • Define (abbreviated)
  • Target Product Profile (TPP)

Indication-finding

  • Gap analysis
  • Searching for candidate indications
  • Prioritizing indications
  • Process guidance for indication selection

Development Plan

  • Product Development Plan (pre- and clinical)
  • Scientific advice meetings with regulatory authorities
  • Definition of requirements for clinical trials

The Target Product Profile – the kickoff to commercial success

A Target Product Profile, or TPP, is a document that is introduced to facilitate the successful navigation of the approval process for an investigative drug product or medical device.

A TPP is a dynamic document that should be updated throughout the drug/device development process. When used to best effect, it gives detailed and up-to-date information regarding the commercial and intended therapeutic goals of the product, in relation to the intended development plan that is needed to achieve those goals. In our experience, a TPP represents a realistic rather than an optimistic view of the goals of product development.

Market authorization – navigating the path to market access

Classifying your medical device is always the first step on your way to get access to new markets. But even this first step isn’t always easy. Different countries apply different systems for classification. Furthermore, proof of conformity steps and procedures vary across different countries. Palleos’ network of experts provide guidance through this sophisticated process.

Let's start a new study together

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