Bioanalytical Data Audits/Laboratory & Validation Evaluation, Chemistry/Manufacturing/Controls, Consulting, Drug Master File Dossiers, Electronic Submissions Preparation, GMP Compliance, Process Validation, Quality Assurance/Control, Stability Studies/Testing, Technology Assessment
DS InPharmatics, a CMC and Regulatory Affairs consulting firm, combining in-depth technical knowledge of product development with regulatory strategy and content authoring for all phases of the review and approval process. CMC HealthChekTM is a comprehensive gap analysis and risk assessment of the scientific content supporting Module 3 CTD. Identify potential problems before you file and align cross-departmental goals to identify the data and information you need for a successful review.
Our multi-disciplinary teams of seasoned CMC professionals can guide your manufacturing and quality programs to success from start to finish, or fill in specific gaps in your in-house team. We know the pitfalls that can occur as a drug is scaled-up for clinical and commercial production. Our experienced CMC consultants troubleshoot difficult technical issues providing you with ‘in-house’ scientific expertise and management of contractors. Whether your needs are comprehensive or tightly focused, DSI will help keep your drug development program on track and under budget.