Exclusive Synthesis

Achieve your goals more easily, safely and rapidly.
The ability to develop innovative synthetic processes, combined with proven know-how in the handling of hazardous chemicals and reactions, makes Dipharma your optimal choice for Exclusive Synthesis services from discovery to the commercial stage.
We provide you with tailor-made development and manufacturing of new and complex molecules, all the required analytical and regulatory assistance, as well as support in pre-formulation activities.

Medicinal chemistry

Custom synthesis

Stable label synthesis

Route selection

Process development

Analytical development

Technology transfer

Analytical validation

Reference standard and impurity qualification

Preliminary stability studies

Solid state characterization

Quality by Design (QbD) approach

Determination of critical process parameters (CPP)

Identification of critical quality attributes (CQA)

Process validation

ICH stability studies

CMC regulatory support

Product release and retention

Lifecycle management

IP protection

Extensive batch size range, from 0.1 kg to 1,000 kg

Project Management

A project should run like clockwork. Since we genuinely care about your peace of mind, we guarantee to offer you a true turnkey service, with all the assistance required throughout the different project stages.

Our approach to Exclusive Synthesis pays special attention to:

  • the requirement for absolute confidentiality;
  • frequent, open and honest communication between the parties;
  • the flexibility required to accommodate the project’s needs within the Dipharma organization;
  • the pro-activity of our skilled professionals aimed at quickly finding the best solution for your project;
  • the objective and realistic planning necessary to control the project development with continuous progress tracking;
  • careful risk assessment to minimize the impact of issues and changes and manage them actively.