Regulatory Intelligence Services, global Regulatory requirements

Healthcare companies across the world require strong Regulatory support to make important decisions like expanding their product portfolio or to market their products across multiple geographies. Enroute they face critical challenges like knowing local dossier requirements new guidelines, ingredient & claim analysis, labeling & packaging requirements, import regulations, local GxP requirements, etc. In such scenarios, there is an undeniable requirement to ensure that companies are aware of these existing geo-specific regulations and also of any forthcoming guidelines to be published. It then becomes essential that Regulatory Intelligence(RI) addresses all these challenges accurately. There arises the need of accurate Regulatory intelligence and strategies to know the exact Regulatory requirement and to provide the highest quality submissions to agencies globally.

Regulatory Intelligence Services

With a robust network of local affiliates in more than 120 countries and coordination with Health Authorities (HAs), Freyr’s Regulatory Intelligence(RI) team can address any query or requirement of companies across the globe. The team adheres to the best ethical practices as defined by RAPS & SCIPS, for collating Regulatory and market information from various sources.

Freyr Expertise

• Exhaustive coverage of global Regulatory requirements

• Complete spectrum of comprehensive and real-time Regulatory Intelligence services across:

• Product Type: Drugs, Devices, Biologics, Veterinary Products, Consumer Products, OTC Products, Nutraceuticals

• Regulation Category: New Guidelines, Guidelines Amendment, Pharmaceutical Development, Manufacturing, Quality, Clinical & Non-Clinical, Stability & Storage, Validation, Packaging & Labeling, Pharmaceutical excipients, Impurities, Artwork & Promotional Material, Recall alerts, Safety & Pharmacovigilance (PV), Warnings, Submission Formats, Others

• Proprietary Regulatory intelligence solution – Freyr INSIGHT

• Instant access to an entire range of authoritative Regulatory information for informed decision making