Regulations pertaining to pharmaceutical products are continuously changing and creating challenges for global pharmaceutical industry. This affects the regional and global regulatory requirements for product approval. Therefore, it is important for pharmaceutical businesses to implement a robust regulatory strategy.
Regulatory strategies are important for successful product development and subsequent market access. An effective regulatory strategy aligns a company’s business strategy with their regulatory activities for a specific product, to identify which gaps need addressing. We at DDReg monitor regulatory trends and offer expert advice on opportunities and challenges that pharmaceutical companies face as they navigate the dynamic world of regulations.
DDReg offers comprehensive and customized regulatory services. Our services in this specialized pharmaceutical area are included below:
- Registration Strategy in Emerging Markets and European Union
- Regulatory Feasibility Analysis
- Legal Status Switches – Rx/POM to OTC/P & GSL
- Product Filing and Variation strategies
- Advisory on CMC data generation for successful filing
- Change Control Strategies
- Subject Matter Expertise
- Query Responses strategies
As a globally recognized regulatory consulting service provider, DDReg offers expertise in the development of strategies for registration of pharmaceutical products in emerging markets, European Union and US market. Our services include legal status switches from Rx to OTC or P&GSL, product filing and variation strategies, CMC data generation for successful filing, change control strategies and subject matter expertise.