R+D / Regulatory
This Division is widely experienced in developing products and preparing regulatory files for licence applications on a worldwide basis.
The main activities of this division are:
- Development of new products or variations on currently known active ingredients, with the aim of modifying their release, improving dosage, and achieving new ways of use or indications.
- Development of generic products and the preparation of regulatory files for licence applications. Such products to be produced in RJ facilities when licenses are granted.
- Development of freeze-drying products:
- Joint research with Oryzon Genomics via the company, Geadic Biotec AIE, for the development of diagnostic methods and oncological therapies based on genome analyses of tumour tissues. The first product itself GynEC-DX is a molecular diagnostic test for endometrial cancer screening.
Clinical trial results were presented at the Congress of ESGO in Milan in september 2011 (poster)
RJ Group is a member of the Pro-Farma plan of the Spanish Ministry of Health and Consumption, and receives project funds from the CDTI (Centre for the Development of Industrial Technology) of the Ministry of Industry, as well as ACCIÓ-CIDEM of the Autonomous Government of Catalonia (Spain).Pharmaceutical development
- Documentation searches
- Selection of API suppliers
- Analytical method development and validation
- Development of variations in form, dosage and therapeutic action
- Production of test batches and process validation
- Stability studies to ICH guidelines
- In vitro tests and preliminary evaluations
- Preparation of Regulatory documentation and reports to support license applications with health authorities globally
- A highly experienced technical Regulatory team with global expertise particularly in Europe and the US
- Preparation of regulatory dossiers for license applications in European and non EU countries, in NEEs and e-CTD formats using specific software packages
- Specific expertise in the European regulatory and application processes, with national or decentralized procedures. Full Regulatory support service from document preparation through to marketing authorization including post approval activities (variations and/or re-validations).
Reig Jofré’s professional team can offer wide experience in coordinating and carrying out ADME(T) pre-clinical and clinical (Stage I-IV) studies, which are necessary for the development of both RJ and third party client products. RJ has a Mass Spectrophotometry (LC_MS/MS) service, specializing mainly in Bio-analysis, with a GLP (Good Laboratory Practice) certification.
Experts in the production of:
- Bioequivalence Studies
- Clinical Pharmacokinetics and Bioavailability Studies
- Drug Interaction Studies
- Pre-Clinical Pharmacokinetics
- Pre-Clinical Toxic- kinetics
- Metabolite Identification & Analysis