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Regulatory Rules, Opinions & Thoughts
FDA 513 (g) Submissions – Decode the Device Classification

FDA 513 (g) Submissions – Decode the Device Classification

Regulatory Operations

For the betterment of healthcare enabling the end user get ultimate benefits of safety and efficacy, there is always a reserved space for invention in the field of medical devices. With the technological development, medical device manufacturers are always on their toes to come up with the best possible innovative products. As the invention takes […]


DMF Types and the Significance of FDA’s clarity on the Type III

DMF Types and the Significance of FDA’s clarity on the Type III

Ahead of nearing mandatory eCTD deadline, 5/5/2017, to clear the confusion surrounded, the Food and Drug Administration (FDA) of United States has clarified what exactly it is looking for in the Type III Drug Master File (DMF) submissions. Before jumping straight into what exactly the Type III DMF refer to, let us discuss the DMF […]


Medical Writing Vs Science Writing

Medical Writing Vs Science Writing

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Medical Writing industry is on an upward surge, mainly driven by an increasing demand in Emerging markets to have high-quality documents authored to support timely drug approvals. At the face of the demand, more than the perfection in the domain, organizations should focus on obtaining clarity on what exactly is medical writing than being confused […]


Submission Types for FDA’s Upcoming eCTD mandate

Submission Types for FDA’s Upcoming eCTD mandate

DMF, eCTD, Regulatory Operations, Submissions & Publishing

As we all are aware, the United States Food and Drug Administration’s (US FDA’s) electronic Common Technical Document (eCTD) requirement is nearing the deadline. Another couple of months to go; by May 5, 2017, all pharmaceutical, biologic and generic manufacturers must submit submission types New Drug Applications (NDAs), Biologics License Application (BLAs) and Abbreviated New […]


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?

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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 […]