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Regulatory Rules, Opinions & Thoughts
Key Artwork Touchpoints and The Need of an Expert Regulatory Partner

Key Artwork Touchpoints and The Need of an Expert Regulatory Partner

Artwork & Packaging, Regulatory Operations

The artwork and labelling functions are under constant pressure when it comes to increasing demand towards reducing drug’s/device’s time-to-market. Besides time-bound pressures, the accuracy that needed to be aligned with health authority validation requirements challenge organizations’ compliant artwork pack management capabilities. Even a single error might result in product recalls, fines and heavy cost burdens. […]

EMA eSubmission Roadmap

EMA eSubmission Roadmap: Your guide to future MA application format requirements

eCTD, Upcoming Mandates

Life Sciences, as an industry is rapidly evolving, so does the Regulatory requirements to sustain in the industry. With a goal to spread digitalization across each and every aspect of market authorization of medicinal products, national drug regulatory authorities across the Europe along with the European Medicines Agency (EMA) have recently updated a document titled […]

DMA Announcement eCTD VNeeS Format

DMA announces timelines to phase-in eCTD and VNeeS formats

Upcoming Mandates

The latest announcement from the Danish Medicine Agency (DMA) specifically points out elimination plan for NeeS format and emphasizes the consequent transition to eCTD for human domain / VNeeS for veterinary domain as directed in the eSubmission Roadmap. With the reports, it is to understand that the electronic format requirements will apply to both new […]

2017 Regulatory Mandates

2017 and Farther

Upcoming Mandates

Gear up to be Compliant The future of Pharma Regulations has never been so complex and challenging and at the same time has never been so easy-to-deal with provided the burgeoning section of Regulatory Intelligence service providers feeding the industry with continuous health authority updates and requirements. Setting forth clear cut guidelines to be compliant […]

Top Regulatory blogs 2016

Top Blogs 2016 – Relook and Realign

Freyr Announcements

As the year-end is drawing nearby, it’s time to retrospect on all the Regulatory actions that the Pharma industry stood by to fall in compliance with Health Authority mandates. It is worthwhile to reflect upon the influential industry trends, HA guidance documents and major industry challenges that we’ve been covering in the last 12 months. […]

Throwback 2016

Throwback 2016

Freyr Announcements

Regulatory Guidelines for the Pharma Industry, so far in ‘16 In an ever changing world of Life Sciences regulations, the Pharma industry has seen many new mandatory requirements from the health authorities worldwide. Right from the Food and Drug Administration (FDA), European Medicines Agency (EMA), Therapeutic Goods Administration (TGA), the Health Canada (HC), the Saudi […]

Cosmetic Production License in China

The New Cosmetic Production License in China. What should you be aware of?

Labeling, Regulatory Operations

The China Food and Drug Administration (CFDA), since December 2015, has been eyeing on the new production licenses for cosmetics (both for new products and exchange the old licenses for existing products) to continue cosmetic manufacturing activities in the region. With the deadlines set and nearing by. what should local manufacturers be aware of? Here […]

Clinical Pharmacology section of drug labeling

FDA releases final guidance on Clinical Pharmacology section of drug labeling

Home, Labeling, Regulatory Operations

Is it the clinical pharmacology section of generic drugs and biologic’s labels requiring your attention? Are you chalking out a plan to gather the related data? Then it is the time you should know about Food and Drug Administration’s (FDA’s) finalized guidance on labeling. Here’s a quick overview. What is Clinical Pharmacology? Clinical pharmacology denotes […]

Health Functional Food

Health Functional Food – Get an Overview at this Live Webinar

Regulatory Operations

In order to supplement the usual diet, sometimes humans who need medical care are advised to take certain kind of food supplements which are generally referred as Health Functional Foods (HFF). To enhance and safeguard human health, these functional foods are set to contain certain nutrients and substances in a more concentrated form which intend […]