Expectations of regulators, sponsors, and investors are met through efficient and well-designed quality systems and the implementation of a suitable development-stage. Several firms have unique requirements that are optimally managed through tailored quality systems and standard operating procedures. DSI develops or reviews Quality Management Systems to guarantee compliance for a firm’s current stage of operation.
Image Credit: DS InPharmatics
Pharmaceutical quality management
Compliance to current Good Manufacturing Practices (cGMPs) is vital for businesses and patients, and is an expectation of the Food and Drug Administration. Current pharmaceutical and medical device manufacturing is complex and needs high levels of experience in GMPs to guarantee compliance.
It is important to make sure your Contract Manufacturing Organization (CMO) or Contract Laboratory Organization (CLO) meets or exceeds FDA regulations in today’s highly regulated environment. To fulfill the FDA’s requirements under 21 CFR parts 210, 211, 820, and 11, firms need to have robust quality systems and processes, and a distinct supplier qualification process. DSI has the knowledge and industry experience to complete and manage these processes for any organization.
DSI: Your reliable partner for pharmaceutical quality systems
DSI has the ability to work with companies to ensure all processes are compliant by completing a Quality Gap Analysis or independent GMP audits. Whether a firm faces challenges with manufacturing, packaging, aseptic processing, laboratory research, labeling, validation, Standard Operating Procedures (SOPs), training, corrective and preventive actions, product adulteration, storage for raw materials, risk management, or other quality problems, DSI has GMP services that will offer the quality operations and systems, alongside the manufacturing expertise needed to aid companies in success.
DSI’s Quality Gap Analysis professionals spend a large amount of time on-site at the facility of firms, investigating all areas of the quality systems and manufacturing operations. DSI works with organizations and reviews the following:
- Personnel qualification and staffing
- Quality manual
- Change control
- Deviations
- Investigations
- CAPA
- Document management
- Electronic quality management systems
- Process validation
- Cleaning validation
- Equipment qualification and validation
- Manufacturing batch records
- Packaging batch records
- Part 11 compliance
- Analytical method validation
- Supplier qualification program
- Internal audit program
- Raw material testing and controls
- Environmental monitoring
- Inventory management
About DS InPharmatics 
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.
In April 2021 we were thrilled to announce that DSI has just become part of ProductLife Group.
French-headquartered ProductLife Group (PLG) is well-known in the Life Sciences market. It has a track record of successfully managing global outsourcing programs and insourcing services for its international client base. The company is on a mission to help transform human health outcomes by optimizing regulatory affairs, safety & vigilance, and quality compliance for life sciences organizations worldwide.
The fit between our two organizations could not be more perfect. We will complement PLG's growing biotech services portfolio. US biotech sponsors recognize DSI as a leader in consulting for go-to-market strategies and RA pre-market consulting. At the same time, PLG has a strong reputation for managing end-to-end outsourcing of regulatory affairs and pharmacovigilance activities worldwide.
Our merger with PLG will harness our combined strengths, offering our clients on both sides of the Atlantic support with their developed drugs approvals and post-approvals compliance, plus advisory services on the best market strategies to deliver a rapid ROI on their development. Together we will offer our clients increased pharmacovigilance capabilities - including a QPPV; pharmacovigilance consulting; and a fully validated safety database - as well as complementary toxicology-related services; RIM/electronic document management services; and support for medical device regulatory requirements.
We see enormous potential in this new chapter for DSI and you, our clients. As a PLG company, we have the opportunity to become part of a global force in life sciences regulatory and compliance solutions and services, and we're incredibly excited to add our momentum to that effort.
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