As an exploratory product edges closer to commercialization and finally to market, the CMC information is gathered, preserved, and updated for both the drug substance and drug product. DSI has prepared a number of successful CMC and quality sections of regulatory submissions. These include meeting packages, INDs and CMC Amendments, DMFs, NDAs, post approval CMC Supplements, Canadian NDSs, BLAs, European IMPDs and MAAs, and post approval variations IMPDs.
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Drug Development needs innovation, creativity, and a multiple disciplinary method in gaining a successful path to approval. A successful program can offer a valuable opportunity for a drug development firm.
The similarities in regulatory compliance between both small and large molecules means DSI is optimally positioned to aid in development and guidance for a successful, efficient drug development program and can create a valuable opportunity for any firm. DSI have a multidisciplinary team that involves in-house regulatory specialists, CMC, and subject matter experts who can enhance a firms likelihood of avoiding a clinical hold or a complete response letter due to CMC concerns.
DSI has an exceptional history of first-cycle FDA approvals which is evidence of their ability to be a successful FDA liaison and guarantee regulatory alignment each step of the way, from concept to commercialization. They offer regulatory advice and problem-solving in addition to advocacy on a firm’s behalf.
In some cases, clinical studies or IND programs could be put on clinical hold, but DSI has the capabilities to get involved and work with the FDA to put drug development programs back on track. DSI has an established process for FDA planning, execution and submissions in order to accomplish both development and corporate objectives. This is reflected through their extensive history of success with the agency and many returning clients.
The traditional method of drug development through the 505(b)(1) approval pathway takes an average of 12 years from start to finish. Conversely, a 505(b)(2) development program can be accomplished in just two to five years, however, this condensed development pathway needs expertise. DSI is skilled at directing the regulatory waters surrounding 505(b)(2).
The DSI team has particular skills in de-risking and condensing development programs. Specifically, they design development plans to obtain and present data, study reports and informed arguments to meet the strategic requirements of a company, address regulatory needs and satisfy the needs of target markets, which are usually niche markets.
Exacting feasibility assessments, gap analysis and common work requests (for example, IND, pre-INDs), means each step DSI takes moves toward feasible product approval, no matter the product form or therapeutic indication at hand.
Want more information on Registered Starting Material (RSM) Pharma Service? Feel free to contact us.
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 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 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.
This document provides an agenda for a workshop on API regulatory starting materials. The workshop will cover defining starting materials according to guidelines, applying for CEP certification, risk assessment, handling post-approval changes, and appropriate controls for starting material manufacturers. Attendees will learn about starting material definitions, challenges in submissions, differences for generics, and workshops on defining suitable starting materials and defending starting material choices. The target audience is those involved in API manufacturing, quality assurance, and regulatory affairs.
Are you interested in learning more about Key Starting Material (KSM) Pharma Service? Contact us today to secure an expert consultation!