DS2DP-Consult offers a service portfolio built on proven professional experience, a deep mastery of pharmaceutical requirements, and the expertise to deliver reliable, robust, and compliant solutions throughout the entire drug lifecycle.
Development Support
We offer tailored guidance covering the entire pharmaceutical development cycle, from early-stage raw material characterization and qualification to marketing authorization (MA) for finished products.
Analytical methods
Development, validation, and transfer of stability-indicating methods
Regulatory File
Gap remediation, deficiency letter responses, and dossier audits
Stability studies
Protocol design (bracketing, matrixing, photostability, etc.), study monitoring, and evaluation of results
Packaging
Research and development of primary packaging
New technologies
Innovative platforms, devices, and formulations
Clinical Trials
CMC support for Phase I-III clinical trials
Industrial support
We also support you post-marketing to guarantee the ongoing control and compliance of your product throughout its lifecycle.
Site Support
- Quality Control Support
- Oversight of regulatory stability studies
- Quality Audits
- Setting up analytical capabilities within CDMO
Regulatory Affairs
- Dossier Module 3 authoring
- Responses to health authority questions
- Support CMC support throughout lifecycle
- Pilot and clinical batches stability programs supervision
Intelligence & Monitoring
- Regulatory
- Scientific
- Innovations
- Trends
Other Services with partners
DS2DP-Consult also relies on a network of specialized partners, rigorously selected for their proven expertise and high-quality services, to deliver comprehensive and fully managed solutions
Evaluation of leachable and extractible study
Dissolution
Particle size Distribution determination
QC API
Impurity identification
Toxicological study support
Permeation study
API caracterisation
