Technical assistance

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Advice on the choice of generics

We synergise our product and market knowledge with the strategic direction of our customers.

Feasibility study

Taking into account the premises and equipment of our customers, we determine which products to develop.

Proposal for rare molecules and their DMF

Along with traditional raw materials, Polypharma offers a range of ’specialities’, which are less common in the pharmaceutical products market. 

For example:

  • materials whose physical characteristics have been modified (by micronisation or coating),
  • microencapsulated materials (extended release),
  • granulated active substances with excipients (DC premix).

The ‘specialities’ aim to improve the effectiveness of the finished formulations and to reduce production costs.

Provision and follow up of technical dossiers

We develop and adapt the technical dossiers of the products chosen by our customers and supply them with the necessary documentation to register and obtain marketing authorisations (DMF, GMP etc).

We can develop specific solutions in line with our customers’ requirements and technical facilities.

The technical dossier is provided in the context of a partnership contract.

More than 150 dossiers have been developed since company inception.  Each year new dossiers are added, according to market evolution and needs. We monitor patent expiry dates and plan carefully in order to be ready to propose dossiers for generics within a short time period following patent expiry.

The technical dossier includes all the information and elements necessary for the manufacture of a generic medicine: description of premises and equipment, formulation, explanation of manufacturing conditions according to the product’s galenic formulation, tests, stability studies etc.

Dossiers comply with ICH guidelines.

Please contact us if you wish to have access to a standard overview of a technical dossier as well as the list of available dossiers.

Provision of DMFs and EMFs

In cooperation with our manufacturers, the synthesis of most of the active ingredients is made according to our DMFs.

For registration purposes, we can supply the DMF of our active ingredients.

Our DMFs comply with ICH Guidelines.

Delivery of excipients with EMF is also possible.

Supply of samples for registration of contractual products

On request we can supply samples of active substances, as well as SCR’s & impurities necessary to carry out analyses.

Ensured presence of qualified personnel for validation batches

We provide support to our customers throughout the production of trial batches in the laboratory as well as three validation batches.  Our technical team visits the customer’s production site and works with their team.  If necessary, we offer assistance with industrial production.

We offer regular follow up during the contractual period.

Supply of raw materials

Our active ingredients are produced by internationally recognised manufacturers.

We develop and apply new synthesis routes with the aim of ensuring better competitiveness and higher quality.

Polypharma also delivers active pharmaceutical substances which are difficult to find on the market.

Polypharma offers practically every pharmaceutical excipient and gives advice during the selection process.  We can advise you as to their specific effects on your pharmaceutical or cosmetic formulations.

We do not supply our products in countries where there may be a conflict with existing patents.  However, responsibility for the final decision rests with the buyer.