Regulatory Affairs
Advance Your Regulatory Excellence with DDReg’s End-to-End Compliance and Market Access Solutions. DDReg offers comprehensive regulatory affairs solutions designed to support pharmaceutical and biotechnology companies throughout the product lifecycle. Our services encompass strategic planning, technical execution, and continuous regulatory support across critical areas such as Due Diligence, Gap Analysis, and New Product Authorizations. We deliver customized, end-to-end solutions that accelerate market entry and reduce time-to-approval—empowering your business to make informed decisions and achieve commercial success across global markets.
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LCM Support
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Our Comprehensive Regulatory Affairs Approach
The regulatory landscape in pharmaceutical affairs is ever-changing. Global regulations are shifting, submission requirements are becoming more intricate, and the need for compliance with international standards is paramount. Pharmaceutical companies face significant challenges obtaining timely approvals while adhering to these varied global requirements. This complexity necessitates specialized regulatory services backed by expert knowledge, dedicated resources, and advanced technology.
By collaborating with the right experts, companies gain a competitive advantage while improving efficiency, reducing risks, and shielding themselves from compliance and financial issues. Pharmaceutical companies must partner with experienced regulatory affairs service providers who understand both regulated and emerging markets. With subject matter expertise, high-end technology, and our robust RIMS platform, DDReg delivers comprehensive regulatory solutions so you can focus on core competencies, accelerate product approvals, and navigate the intricate regulatory landscape with agility.
Global Regulatory Expertise & Process
Partner with DDReg for compliant regulatory services. We are a globally reputed regulatory affairs services provider with decades of experience in over 120 countries. Our teams have collaborated with global authorities across regulated and emerging markets, developing tailored regulatory strategies for the global filing of products, conducting gap analysis & remediation, performing regulatory due diligence , and securing new product marketing authorizationsfor both drug substances and drug products. Our services extend to product lifecycle management, including variations and change control planning, CMC services, API & DMF services, and much more.
Our global eCTD regulatory submission management and publishing services utilize high-end RIMS tools and industry best practices to overcome submission management challenges—ranging from legacy document conversions to SPL publishing and e-Conversion for agencies such as the US FDA, EMA, UK MHRA, Saudi FDA, and TGA Australia. Additionally, our extensive network of local liaison individuals ensures seamless product submission and lifecycle management, even in regions with limited regulatory updates. This integrated approach enables pharmaceutical companies to adapt to evolving regulations, address complex regulatory challenges, and streamline the approval process efficiently.
Our Regulatory Affairs Services
01
Regulatory Strategies
The pharmaceutical industry operates under stringent regulations to ensure the safety, efficacy, and quality...
02
New Product Marketing Authorizations
Navigating marketing authorization is a complex and time-sensitive process. Every country has its own regulatory framework...
03
Gap Analysis and Remediation
In the highly regulated pharmaceutical industry, maintaining compliance is critical. Regulatory gap analysis helps identify deficiencies in technical documentation...
04
Regulatory Due Diligence
Regulatory issues arise unexpectedly and can create significant strain on a company’s resources. As such, it is advisable for all companies to carry out regular and frequent regulatory due diligence and audits...
05
API & DMF services
Drug Master Files (DMFs) contain confidential and detailed information regarding API processes—from manufacturing to storage. DDReg’s DMF Services deliver precise...
06
CMC Advisory
DDReg’s CMC services are dedicated to assisting customers in developing robust and an efficient regulatory strategy through all development phases - authoring...
07
Post Approval Life Cycle Management
Maximize product value with expert pharma lifecycle management. Our dedicated team ensures that your product remains on shelves and compliant with ever-evolving regulations through strategic post-approval management...
08
Certification Services
Partner with DDReg to navigate the complex process of regulatory certification of pharmaceutical...
09
ANDA and MA Holder Services
Our comprehensive services support both Abbreviated New Drug Applications (ANDA) and Marketing Authorization processes.
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Publishing & Submission
Our comprehensive digital solution transforms traditional paper dossier submissions into a streamlined electronic format. With robust infrastructure and cutting‐edge management processes...
