European variations regulatory consulting services
The new variations regulation (EC) 1234/2008 effective January 2010 applies for human and veterinary marketing authorizations granted through mutual recognition process (MRP), decentralized (DCP) or centralized procedure (CP). The new regulations also apply to purely national authorizations but can be implemented gradually; some competent authorities that are proactively adopting the regulations, from 1 January 2010 for purely National Authorizations, include the UK, Sweden, the Netherlands, Germany and Belgium.
2010 Variations and Lifecycle Management Implications
A completely new system of product variations and extensions is being put in place by the EU Commission effective January 2010 that is clearer and more systematic than ever before. This time around, unlike the regulations previously introduced in 2003, even National Procedures have to follow the European system to ensure a harmonized approach. The impact on product lifecycle management goes without saying. It's a change you need to address now if you have, or plan to have, products on the market in Europe governed by EU Commission regulations. Take advantage of a more streamlined regulatory approach with clearer requirements (it's more than CMC now), more flexibility and efficiencies for post marketing activities. And, ideally the waiting queues for new product filings may become more favorable due to this new system if utilized effectively by industry.
Pharmaceutical | Biotech | Medical Device | Regulatory Consulting
PAREXEL Consulting offers flexible and comprehensive advice and services to help you navigate this new requirement no matter what your product and therapeutic focus. Contact us today for an executive briefing on the regulatory impact of 2010 Variations regulatory change, and how we can assist you to optimize your products' value on the market. Training, effective communications and interactions with authorities, variations prioritization and planning, implementation and ongoing management are some of the ways we can help. Precisely tailored services and expertise to meet your specific needs. Partner with us to establish a working system for your company with this unfolding dynamic in the EU regulatory environment.
Key Ways in Which We Can Assist You:
- Executive briefing and internal training on 2010 Variations regulatory requirements
- Advise on proposed classification and grouping of variations to ensure the best outcome for you
- Protect your interests by influencing the process through good reputation with agencies: both CA and EMEA
- Guidance on the best course of action through experience of the inner workings of the agencies
- Apply our extensive knowledge of variations of numerous products strategically and operationally to your products
- Leverage our worldwide intelligence to define a Global Strategy for you beyond the EU to the US, Japan, China, Korea and Latin America
Service Benefits:
- Devise an EU regulatory strategy that best fits your company, your products
- Extensive resources and expertise that can take advantage of efficiencies and help eliminate time lags
- Flexibility of the types of support we can offer, short and long term
- Clinical efficacy and safety, clinical pharmacology, nonclinical, chemistry, manufacturing and control, labelling competence
- Compliance support with cGMP, GLP, GCP
- Clinical and pharmaceutical development support
- Agency Liaison Europe-wide and worldwide for strategy and execution
- Expertise among all drug classes, pharmaceutical forms and therapeutic areas
- Translation in 23 plus languages
Contact Us
For further information and to get in touch with our experts, please use our contact us form and type "EU Variations" in the comment field so we can assign the right expertise for further discussion. Thank you!