Regulatory Services in Mexico
Regulatory Services in USA
Regulatory Services in Canada
Regulatory Services in Malaysia
Regulatory Services in Singapore
Regulatory Services in India
Regulatory Services in China
Regulatory Services in Indonesia
Regulatory Services in Philippines
Regulatory Services in Vietnam
Regulatory Services in Morocco
Regulatory Services in UAE
Regulatory Services in Kenya
Regulatory Services in Turkey
Regulatory Services in Saudi Arabia
Regulatory Services in Jordan
Regulatory Services in Egypt
Regulatory Services in Colombia
Regulatory Services in Japan
Regulatory Services in South Korea
Regulatory Services in Kazakhstan
Regulatory Services in Italy
Regulatory Services in Latvia
Regulatory Services in UK
Regulatory Services in Belgium
Regulatory Services in Spain
Regulatory Services in Australia
Regulatory Services in South AfricaRegulations 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.
