Portfolio of services
Our services:
We offer design, evaluation, development and analysis of formulations. For this we use modern techniques and instruments, structured processes, the predictive power of algorithms and extensive knowledge of relevant guidelines and regulations.
We also offer our clients judgement and expertise, dialogue, the spirit of cooperation and flexible customization of solutions. We have the ambition to support you sustainably to reach your goals.
- Rational design (scientific, technical, regulatory, economic)
- Theoretical/in silico evaluation of the formulability of APIs
- Development of analytical (ATP) and target formulation profiles (TFP) together with the customer
- Disease/skin type-specific formulation development
- Concept development for medicinal products, medical devices and cosmetics
- Consulting/strategy for value optimization of data packages from early phase/out-licensing projects
- Risk assessments, scenario analyses
- “Quality by Design” (QbD) concepts according to ICH Q8
- Patent and patent circumvention strategies
- Protection/exclusivity strategies other than patents (silent know-how, proprietary excipient specifications, processes)
- Reverse engineering of marketed products
- Technology evaluation/scouting for formulation technologies
- CMC and technology expert statements in due diligences
- Physicochemical characterization of APIs
- Thermodynamic and kinetic solubility screening in pharmaceutical excipients
- Selection of suitable excipients in consideration of the product category and the requirements of different geographies (EU, USA) including the creation of critical material attributes (CMA) and “justification of excipients”
- Quality by Design (QbD) according to ICH Q8: Creation of a target profile for a formulation (QTPP), determination of Critical Materials (CM), Critical Process Parameters (CPP) & Critical Quality Attributes (CQA)
- Determination of formulation properties (e.g. buffer systems and necessary capacities, pH optima, chemical and physical stabilization, rheological target profile etc.)
- Targeted modification of the distribution behaviour between oil and aqueous phase
- Development and optimization of preservative systems based on the concept of the “freely available” preservative concentration
- Formulation optimization
- Cosmetic optimization taking into account the skin/disease pattern
- Rheological characterization, prediction and optimization of physical stability based on rheological profiles
- Screening and compatibility of packaging materials
- Extractable & Leachable (E&L) studies in cooperation with partner
- Development of suitable analytical methods for purity and assay testing
- Establishment of robust extraction processes for APIs and degradation products from complex (semi-solid) matrices
- Establishment and implementation of stress tests (drug substance/drug product)
- Proof of the suitability of an analytical method by pre-validation according to ICH guidelines (non-GMP)
- Quality by Design/statistical optimization of chromatographic methods
- Conversion and method transfer between HPLC and UHPLC technology
- Development of stability strategies against hydrolytic and oxidative degradation; experience in stabilizing isomeric forms in the product
- Execution of explorative stability studies according to ICH and generation of shelf life predictions
- Method validation and stability studies under GMP in collaboration with partner
- Method transfer
RaDes established a range of powerful in vitro and ex vivo models for de-risking dermal development projects and to assess the quality and performance of topical products. These models provide support through the entire lifecycle of a drug product from compound and formulation selection to bioequivalence testing and post-approval changes. High-performance analytical equipment is in place for selective and sensitive analysis.
- Process development and process risk analysis including CPPs
- Optimization of the process temperature profile with regards to chemical and physical stability
- Scale-Up (risk analysis for industrialization, Design of Experiments (DoE), dimension analysis)
- Process transfer
- Support of clients in developing the regulatory strategy (taking into account the requirements of the respective approval procedures and geographies (EU, USA))
- Support in the creation of the product quality part in study applications (IMPDs, INDs) and approval documents (Module 3.2.P CTD)
- Troubleshooting in development projects and for marketed products
- Establishment of design space using DoE for processes and formulations
- Process optimization and support in process transfers
- Optimization, transfer & life-cycle management of analytical methods
- Risk analysis for the exchange of excipients
- Evaluation of alternative excipient qualities optionally based on DoE