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Pharmaceutical development

Physical
Pricing/Discount Options: Call #2
Unique Identifier: 615a42dc-c99b-44e9-b757-23878146c154

Service Description

RISE Research Institutes of Sweden AB in Södertälje works with pharmaceutical R&D including preclinical research of new candidate drugs. From design to production in the same testbed: - Preclinical in-vitro and in-vivo studies to study target and non-target toxicology. - Drug formulation and new therapies with small molecules, biologics including proteins, oligonucleotides, peptides, mRNA, DNA etc. - Chemical Process development and GMP production to clinical studies. - In vivo studies integrated with bioanalytical and pathology services, supporting from early discovery to preclinical safety testing. - Chemical analysis and characterization, including impurity analysis and stability. - Green chemicals and formulation.

Keywords: Testbeds, toxicology, regulatory safety, process chemistry, drug delivery, drug formulation, drug synthesis, bioassay, drug analysis

Offerings: Testing Laboratory (bioanalysis, wet lab, *-omics, etc.)
TEF-Health Use Case Domain: all
Provider Logo

Provider & Contact

Provider Organisation RISE Research Institutes Of Sweden
Provider Country Sweden
Published Email tef-health@ri.se

Pricing is available to registered users. SMEs receive significant state-aid reductions (GBER) — or, depending on the call, free services during the funded project. Sign in or register to see the price for your organisation.

Operational Details

Service Inputs Annotations, needs of the SMEs.
Service Outputs Based on SME:s requests, e.g. reports.
Dependencies & Restrictions GDPR;Facility costs
Certification Support GLP (Good Laboratory Practice) Certification, GMP (Good Manufacturing Practice) RISE use GMP (good manufacturing practice) in manufacturing of API (Active Pharmaceutical Ingredient), drug product and pharmaceutical analysis. GMP according to eudralex Volume 4, Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, More specifically Article 63(1) of Regulation (EU) No 536/2014.
  • Article 63(1) of Regulation (EU) No 536/2014
  • Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC
  • GLP (Good Laboratory Practice) Certification
  • GMP (Good Manufacturing Practice)
  • RISE use GMP (good manufacturing practice) in manufacturing of API (Active Pharmaceutical Ingredient), drug product and pharmaceutical analysis. GMP according to eudralex Volume 4
Service Standards ISO 15189:2012, ISO/IEC 17025 Accreditation, if necessary.
  • ISO 15189:2012
  • ISO/IEC 17025

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