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Regulatory Rules, Opinions & Thoughts
ANDA first-cycle approvals and the need for eCTD

ANDA first-cycle approvals and the need for eCTD

Ever since the Hatch-Waxman Act came into being, the generic drugs have saved billions for both patients and healthcare systems alike and accounted for 88% of the prescription drugs sale in the United States alone. Though that emphasizes the ever-growing aspect of generic drug market share, it has resulted in mounting difficulties for both the […]


eCTD in Limelight. HPRA to Make Electronic Submissions Mandatory

eCTD in Limelight. HPRA to Make Electronic Submissions Mandatory

Ever since the electronic submissions initiated, there are growing instances that both health authorities and drug manufacturers are being benefitted. Intended to make it the same situation for human medicines manufacturers in its jurisdiction, the Health Products Regulatory Authority – HPRA (formerly known as Irish Medicines Board [IMB]) is now in plans to implement the […]


FDA eCTD Deadline – Benefits and the Approach

FDA eCTD Deadline – Benefits and the Approach

Even though the eCTD (Electronic Common Technical Document) format has been in existence for nearly ten years, now it has become a focal point for pharmaceutical, biologic and generic drugs manufacturers because of the US FDA (Food & Drug Authority) mandate stating that all NDAs (New Drug Application), BLAs (Biologics License Applications) and ANDAs (Abbreviated […]


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

Home

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 […]