Substipharm develops mainly oral or topical dosage forms for the European public generic products market. The oral dosage forms that we develop cover the entire range of galenical forms offered in today’s marketplace:

• solids: powders, capsules, non coated or film-coated tablets, orodispersible, immediate or modified release …
• liquids …

We rely on one side on our internal technical and scientific teams (pharmaceutical chemists, analysts, galenists, pharmacists), and on the other side service companies to whom we entrust the pharmaceutical and clinical developments. The companies are chosen at European or international level for their specific competency after rigorous selection.

Today, our development portfolio numbers more than twenty projects for which we monitor all phases, alone or in association with partners:

• patents evaluation
• selection of drug substances
• pre-formulation / formulation
• setting-up and validation of analysis methods (ICH)
• pilot batch manufacture including the clinical batches
• scale-up in collaboration with our Industrial Department
• validation of manufacturing process
• ICH stability studies
• pharmaco-toxicological studies (topical dosage forms)
• bioequivalence studies (generic versus reference product)
• English drafting of Marketing Authorisation dossier in CTD format in close collaboration with our Regulatory Affairs Department

For all our developments we pay particular attention to the choice of the drug substance and its manufacturer in order to guarantee sustained quality and competitiveness throughout the life of the product. In order to ensure service continuity to our customers, for security, we systematically select and register two separate manufacturers of each drug substance.

Substipharm ensures the supply of developed products based on a controlled network of European pharmaceutical sub-contractors whose quality and competitiveness are validated.

Our Industrial and Logistics Department takes fully in charge:

• industrialisation of new products
• production progress
• customer order progress and management
• drug substance purchase
• customer product supply planning and organisation

Substipharm relies on a complete quality management system notably comprising:

• respect of eurGMP at all stages of product life
• qualification of drug substance manufacturers
• approval of finished product manufacturers and analytical sub-contractors
• audits at regular intervals
• contract and technical agreement redaction and up-dating with all our suppliers
• approval of manufacturing, packaging and testing instructions
• follow-up of validation of manufacturing procedures
• follow-up of pre and post commercial stability programmes
• follow-up of annual product reviews
• complaint management
• change control

Our Regulatory Affairs Department, in close collaboration with the Development teams, write and submit English language CTD format Marketing Authorisation dossiers in the name of Substipharm following the most suitable procedure: DCP, MRP or national.

Dossier redaction together with the follow-up of registrations is assured by pharmacists highly experienced in the French and European regulatory fields, enabling us to reconcile our clients expectations with regulatory authority requirements.

Reactivity and rigour ensure that Substipharm obtains Marketing Authorisations in the best possible time.

Subsequent to granting of Marketing Authorisations and in co-ordination with our customers, we ensure regular dossier updates.

A sustained regulatory watch together with expert consulting ensures our real-time awareness of any modification in the regulatory environment.