Pharmaffiliates-A Perfect Partner for Regulatory Consulting

Published on February 6, 2019

According to a November 2018 research report on the Indian pharmaceutical sector, 2018 had been a stupendous year for the Indian Pharmaceutical Sector.

The US Food and Drug Administration (FDA) has approved a record 741 generic drugs in the calendar 2018, with Indian pharma companies accounting for nearly 50% of the approvals.

Among the abbreviated new drug applications (ANDAs) filed with the US FDA in 2018, 95 are first-time generic drug approvals and 31 of them were received by Indian companies and their subsidiaries.

ANDAs are the reason for this strong position held by the Pharmaceutical sector.

The main pacers in this field of drug approvals were Aurobindo Pharma Ltd, Cadila Healthcare Ltd, Lupin Ltd, and Cipla Ltd.

Over the next few years, the face of pharma sector will not only focus on investments, soaring pricings and opportunities, but the focus will be more on biologics and complex chemistry.

Due to the high demand-supply ratio and 24-hour manufacturing processes, Pharmaceutical organizations usually find it difficult to involve manpower and infrastructure in research and development areas and also in extensive documentation work required in dossier preparation for filing DMFs and ANDAs. For this, they require a perfect partner to cater all their needs under one roof.

Pharmaffiliates Analytics and Synthetics P. Ltd. , an integrated Contract Research Organization (CRO) is a gigantic name in the global market, which offers varied services to Pharmaceutical industries.

Big pharmaceutical giants rely on us for services like

• Custom Synthesis of complex molecules
• Regulatory Consulting
• Dossier preparation
• DMF and ANDA submissions
• Training and Audits
• New Drug Delivery system
• Drug Development

Why choose us for Regulatory Consulting

• Flexibility
• Experience in multidisciplinary projects
• Excellent relations with Health Authorities
• Deep knowledge of legislation and regulatory environment
• Expertise in electronic submissions

Pharmaffiliates is a genuine partner which has the vision to empower the global pharmaceutical industry and support the dependent business entities. At present, Pharmaffiliates has its presence in more than 65 countries.