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DS InPharmatics

Description: 

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.  

 

Services: 

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

Contact Information: 

DS InPharmatics
PO Box 263
Sumneytown, PA, 18084, USA
Phone : 2152724275
Fax :
Internet : www.dsinpharmatics.com
Email : jseibert@dsinpharmatics.com
Contact Person : Jennifer Seibert