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What is Drug Regulatory Affairs & Why It is Important?

Regulatory Affairs is the crucial department for Pharmaceutical, Medical Device, Cosmetics, Herbal, and Food Industry that must comply with the global regulatory framework to ensure safety for human use. Regulatory Affairs helps industries and companies at every stage of product life cycle and to get ready with legal and technical documents and dossier in order to get market approval and registration of products in both domestic and International markets. This is a small guide to drug regulatory affairs about the importance, goal, and functions of pharmaceutical regulatory affairs in India and global market.

What Is Drug Regulatory Affairs?

Drug regulatory affairs (DRA) is a discipline in pharmaceutical sciences that ensures quality, safety, and efficacy of drug products. Drug regulatory affairs in India involves the preparation and submission of documents for drug product approval and marketing for commercial purposes. DRA professionals act as the bridge between the pharmaceutical industry and the regulatory authorities like Central Drug Standard Control Organization (CDSCO) for India, United States Food and Drug Administration (US FDA) for US, and European Medicine Agency (EMA) for Europe. 

Primary Goal of Drug Regulatory Affairs

Drug regulatory affairs primary goal is to ensure that drug product meets regulatory standard set by the country specific regulatory authorities for marketing of medicine. Regulatory authorities are responsible for safeguarding the public health by setting the regulatory framework. Therefore, before marketing of drug product, it must follow the regulatory standard, ensuring the safety, quality, and efficacy of drug product in order to 

Importance Of Drug Regulatory Affairs In Pharmaceutical Industry?

Pharmaceutical regulatory affairs plays an important role in ensuring regulatory compliance of drug products with the regulatory framework of specific countries. Pharmaceutical regulatory affairs  is essential for safeguarding public health by making assurance that only safe and effective drugs reaches to consumers. DRA fosters innovation by guiding companies to overcome hurdles of complex regulatory pathway of product approval, ensuring timely market access.

What Are The Benefits Of Drug Regulatory Affairs?

Pharmaceutical regulatory affairs have several benefits, some of the common are listed below:

  • Drug safety and efficacy assurance 
  • Regulatory compliance of drug products with the required standard 
  • Enhances product approval and market acceptance 
  • Smooth market access on time
  • Monitor safety of drug through post-marketing surveillance (Pharmacovigilance)
  • Ensures high quality and safety drug available to consumers, promoting public health 
  • Establish consumer trust through maintaining  transparency and good regulatory practice 

 What Is The Role of Drug Regulatory Affairs In Drug Development?

Role of drug regulatory affairs in drug development is crucial as it is integral to every phase of drug development, ensuring smooth changes from laboratory to marketing and commercialization. Some key points of pharmaceutical regulatory affairs roles are as follows:

  • Clinical study design and safety monitoring of drugs
  • Regulatory submission of application (IND, NDA, AND ANDA) for product approval and marketing venture 
  • Labelling and packaging of drug products 
  • Product lifecycle management from initial registration to renewal of product 

Major Functions of Drug Regulatory Affairs?

Below are the major functions of pharmaceutical regulatory affairs in India:

  • Dossier preparation and submission to get the registration of products 
  • Regulatory compliance with regulatory standards 
  • Communication with regulatory authorities for submission and approval 
  • Training and audit inspection to confirm the manufacturing process is processing as per Good Manufacturing Practice (GMP)
  • Review and analysis of CMC (chemistry, manufacturing, control) data

How Medwisdom Lifescience Can Help You In Pharmaceutical Regulatory Affairs?

At Medwisdom Lifescience, we are specialized in dossier preparation for pharmaceutical, which is the most important thing for product registration. We offers end to end regulatory solutions with compliance at cost effective rates. We provides regulatory affairs services compliance with specific country regulatory authority. Some of our expertise for pharmaceuticals regulatory affairs includes:

  • Dossier compilation with compliance 
  • CMC documents preparation for product registration 
  • Regulatory submission and timely approvals 
  • Product lifecycle management 
  • Global market consultancy services for regulatory affairs 

FAQs 

What Is CTD Dossier and Why It Is Important?

Common technical document (CTD) is a standardized format for regulatory submissions to simplify the process of product registration or approval. It is important for presentation of product data across the country where we wants our product to get registration.

What Is The Timeline For Drug Product Approval?

The timeline for drug product approval basically depends upon the regulatory authority and the country where you wants your product to market.

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