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Regulatory Rules, Opinions & Thoughts
Cosmetic Product Safety Report CPSR

What should a Cosmetic Product Safety Report Entail?

Cosmetics, Regulatory Affairs

Are you a cosmetic product manufacturer looking to obtain market authorizations across the European Union? Do you know what consists of your mandatory technical documentation need to be submitted for cosmetic products’ market approvals? Well, to market the cosmetic products in the EU, manufacturers as per the EU Cosmetic Regulation should submit a Product Information […]


Structured product labelling: What are its components

Structured product labelling: What are its components?

Home

Managing product information is quite a task. In the stringent world of life sciences, to do so, manufacturers must follow certain standards and procedures which are aligned to FDA’s regulations. Not only do they have to follow the set procedures but they are also required to maintain accuracy and integrity of information to be prescribed […]


Step-by-step Process Overview of Regulatory Artworks

Step-by-step Process Overview of Regulatory Artworks

Artwork & Packaging, Regulatory Operations

With years of time spent on innovating new drugs, life sciences organizations, sometimes, take a backseat to allocate sufficient time for artwork design processes that result in inaccurate and incompliant marketing of products followed by product recalls affecting the overall costs. With defined Regulatory artwork processes, organizations can sustain critical situations like these especially in […]


Regulatory Artwork Packaging Errors You Must Avoid

Regulatory Artwork Packaging Errors You Must Avoid

Artwork & Packaging, Regulatory Operations

Even when artwork packaging is often considered to be a seemingly insignificant back office job, Artwork Pack Management is one of the key processes in the stringently regulated pharma world. For any given pharmaceutical or life sciences company, meeting the ever-changing regulatory-driven requirements of global markets and finding cost-effective ways to stick to compliance standards […]


Anticipated Elimination of Major part of FDA Regulations

Anticipated Elimination of Major part of FDA Regulations

Upcoming Mandates

What does it mean for Drug Approval Processes? In a recent meeting, the US President proposed a crucial deal that could drastically change the regulatory landscape as we anticipate. In a bid to reduce the taxes and regulations related to drug approval processes, the recently elected US President proposed the move, which is expected to […]


FDA’s Ban on Powdered Medical Gloves and Key Factors It Entail

FDA’s Ban on Powdered Medical Gloves and Key Factors It Entail

Upcoming Mandates

In a recent announcement, the US Food and Drug Administration (FDA) asserted the ban on powdered medical gloves will come into effect, beginning 19 January 2017. Citing the evidence that the use of powdered medical gloves poses an unreasonable and substantial risk of illness or injury to patients and other individuals who are exposed to […]


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 […]