Regulatory Intelligence and Strategic Advisory Services
The need for regulatory intelligence, and strategic input has significantly increased in parallel with the ever-changing regulations and rise in complexities surrounding product approval. Be it clinical trials, pharmaceutical product development, or post-submission senior management and other key stakeholders within a pharmaceutical organization require Regulatory Intel and comprehensive strategic advisory support that tackle challenges associated with rapid developments of the regulatory landscape. This ensures rapid market access for pharmaceutical products in desired regions, compliance, increased business value, and market competitiveness.
Hence, partnering with vendors that have the subject matter expertise, industry knowledge, and incorporate innovative technologies and intelligent systems are the solution.
At DDReg, we bring together knowledge, intelligence, and dedication to provide regulatory intel and strategic advisory services for our customers in regulated and emerging markets by helping them anticipate and prepare for changes in the regulatory and drug safety environment. DDReg team gathers and analyzes large amounts of information & data from established and proven sources, explore & understand a wide array of regulatory intel streams and develop strategies for customer organization based on product, market, legal status, clinical & CMC data. With years of industry know-how and skillset, these teams collaborate to provide strategic reports for customer’s needs and facilitate proactive progression alongside regulatory trends to deliver positive results for business models.
DDReg’s Regulatory Intel and Strategic Advisory capabilities include:
Strategy reports based on analysis of regulations & competitive landscape.
Developing clinical & regulatory roadmap for products in existing & new markets, thus facilitating business growth.
Facilitating supply optimization through change controls & variation strategies based on regulatory review of products & sources, carry out impact analysis and disseminating findings to help build tailored supply strategies for target markets.
Providing support in streamlining and integrating compliance processes by developing frameworks to minimize risk of non-compliance or other regulatory risks.
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