It is possible to minimize quality issues and supply chain disruption risks through practical early and routine evaluation of vendor cGMP compliance. This also decreases the possibility of health authority actions like 483s, compliance observations, warning letters, market restrictions, consent decrees, etc.
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Advanced preparation for preapproval inspections demonstratively supports the prevention of surprises during the process of approval and launch. DSI can identify, remediate, and help to lessen the effect of compliance issues, which can cause expensive stock out or interruptions in commercial approval.
DSI has audit expertise in every field, such as nonclinical, clinical, CMC, and other regulated activities. Whether companies require proactive review and refinement of operational processes or need to put an audit program in place in response to prior regulatory contention, DSI can make a successful partner.
DSI’s comprehensive audits of bioequivalence studies and bioanalytical analyzes support the precision of data submissions to the FDA and aid in accelerating drug approval and market launch. When sponsors of pending or approved ANDAs come across FDA challenges to their studies, they often ask DSI to present professional validation of findings.
DSI meets or surpasses all FDA criteria for “audits conducted by a qualified independent expert.” Their panel of scientific and regulatory specialists offers flawless audits that meet and surpass the highest professional and FDA inspection.
Audit services
- Explanations that address regulatory/compliance challenges and requirements
- Customized services that meet study/program needs
- Wide-ranging expertise that meets or surpasses all qualification criteria
- CMO evaluation, selection and contracting
Staff augmentation
For several biotechnology firms, it is not possible to sustain a complete complement of product development experts, from nonclinical researchers to clinical trial specialists, medical writers and regulatory professionals. However, limited access to these experts delays the progress of product development.
In response, DSI has created a unique solution to tackle this issue with our Staff Augmentation offerings. The team at DSI consists of previous industry scientists and subject matter professionals who follow the highest standards of professional conduct. DSI can:
- Employ a complete roster of experts in every field of pharmaceutical, biologic/biosimilar, medical device, and therapeutic product development
- Provide the opportunity of an on-demand team
- Offer a team with the capabilities to step in to enhance a current team, providing advantages of a world-class staff for a low cost
- Cooperate with companies of all sizes on projects of all scales
- Bring a unique insider perspective to each engagement, permitting maximized value of all money spent while hastening a development timeline
Due diligence
Information is the key to managing risk. DSI's Due Diligence services use extensive experience and understanding of the regulatory and product development requirements for success, to:
- Support clients in making informed business decisions
- Offer professionals to perform comprehensive due diligence on the strategic and operational realities of the target
- Serve: Venture Capitalists, M&A Parties and their advisors, Industry Venture Groups, Business Development Departments, Alliances and Co-Development Partnerships
About DS InPharmatics LLC
DS InPharmatics (DSI) provides regulatory, technical, and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.
Since 2007 we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence. Whether advocating CMC strategy, directing CMC operations or developing CMC submission content that represent the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.
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