Regulatory Intelligence Services

We provide regulatory intelligence services to help clients stay ahead of the ever-changing regulatory environment, new developments, and changes in the requirements and guidelines. We continuously monitor regional and local regulatory intelligence information and keep clients updated on any regulatory changes affecting their activities or products.

Our broad country-level presence provides us with a unique opportunity to act as your eyes and ears in the local market. We retrieve, analyze and translate the regulatory information into easy-to-understand language. Our regulatory intelligence service will help you avoid regulatory pitfalls, assure day-to-day compliance, and support your strategic decision.

Our regulatory intelligence services cover regional requirements (European Medicines Agency (EMA), EudraLex, Committee for Medicinal Products for Human Use (CHMP), Heads of Medicines Agencies (HMA) Coordination Group for Mutual Recognition and Decentralized Procedures (CMDh), and many others), as well as local regulatory intelligence EU/EEA member states and CIS countries (National Medicines Agencies, local legislation databases, local lobbying groups, etc.).

Services Offered:

Local regulatory intelligence monitoring across  EU/EEA member states and CIS countries

Regional regulatory intelligence monitoring (EMA, EudraLex, CHMP, HMA and CMDh, etc.)

Provision of weekly or monthly summary regulatory intelligence reports

Impact assessment of all regulatory changes

Immediate escalation of regulatory changes that could impact clients’ operations or products

Ad-hoc interpreting regulatory guidance documents

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Countries covered
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Local regulatory experts
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MAA procedures handled

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