The pharmaceutical industry is a vital part of the healthcare system, providing chemical substances that aid in the treatment, cure, prevention, and diagnosis of diseases. The industry has witnessed significant growth over the years, with spending on medicines expected to reach $1.5 trillion by 2021, with a focus on oncology, autoimmune, and diabetes treatments.
The regulation of medicines varies by country. In the UK, the Medicines Act of 1968 mandates that medicines must be licensed before they can be sold in the country. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating medicines, medical devices, and blood components for transfusion. In the US, the Food and Drug Administration (FDA) is responsible for ensuring the safety and efficacy of drugs and medical devices.
As technology advances, global health authorities are faced with new challenges, resulting in continuous changes to regulations surrounding pharmaceuticals. Barrolex provides services to aid in navigating the regulatory landscape, including pre-registration, new drug approval, plant setup, and regulatory intelligence and strategy. They also offer support for post-approval changes, manufacturing licenses, and distribution points, among others. With their experience and attention to detail, Barrolex aims to provide hassle-free solutions for their clients' pharmaceutical needs.
Barrolex understands the importance of adhering to these regulations to ensure the safety and efficacy of pharmaceutical products. Our team of experts stays up-to-date with the latest regulations and requirements from regulatory bodies around the world. We provide services ranging from pre-registration to post-approval changes and work closely with our clients to ensure their products meet all necessary standards. Our experience in the industry allows us to offer regulatory intelligence and strategy planning, as well as support for distributor identification and setting up distribution points. We also offer services for plant setup and manufacturing licenses for drugs, devices, and cosmetics. Barrolex is committed to providing high-quality services to ensure the success of our clients in the pharmaceutical industry.
New Drugs, SND, FDC, API, Bulk Drugs, Test Licenses, BE NOC, etc. for importers, manufacturers and traders
Regulatory support for FSSAI. Import assistance, Licensing and registration, FSSAI compliance, Product Approval
Medical device registration, Import license, Clarification from CDSCO, Performance evaluation
Registration of biologicals, Import license, Test license, Export NOC, Regulatory support for CLAA
Registration of biologicals, Import license, Test license, Export NOC, Regulatory support for CLAA
Registration of biologicals, Import license, Test license, Export NOC, Regulatory support for CLAA
R.P/C.P
The medicines need to be handled with by a specialist, and for that matter, there is a requirement of a qualified pharmacist in case of retail drug license and in case of wholesale a graduate with 1 years experience or undergraduate having four years experience is must or any Diploma or Bachelor degree in Pharmacy.
Area For Drug Licence
For opening a pharmacy business, the carpet area of the pharmacy must be a minimum of 10 square meters, and in case the application is for both retail and wholesale pharmacy the minimum area prescribed in 15 square meters. The premises must be commercial and adequately ventilated.
I had been struggling to navigate the complex and ever-changing landscape of Indian regulatory services for years, until I found a reliable partner in Barrolex Consultants. Their team of experts not only helped me understand the intricacies of various regulations, but also provided invaluable.
I recently purchased a Miscellaneous product from this company and was blown away by the quality and attention to detail. The product exceeded my expectations and has been an essential part of my daily routine ever since.
cannot recommend Global Regulatory Services enough. Their team of experts provided us with invaluable guidance and support as we navigated the complex and ever-changing regulatory landscape. Thanks to their expertise,
Proactively revolutionize granular customer service after pandemic internal or "organic" sources. Distinctively impact proactive human capital rather than client-centered benefits.
Professionally impact distributed data via value-added experiences. Proacti incentivize 24/365 applications whereas turnkey total linkage. whiteboard multifunctional channels with interoperable value.
Professionally impact distributed data via value-added experiences. Proacti incentivize 24/365 applications whereas turnkey total linkage. whiteboard multifunctional channels with interoperable value.
Professionally impact distributed data via value-added experiences. Proacti incentivize 24/365 applications whereas turnkey total linkage. whiteboard multifunctional channels with interoperable value.
Professionally impact distributed data via value-added experiences. Proacti incentivize 24/365 applications whereas turnkey total linkage. whiteboard multifunctional channels with interoperable value.
Professionally impact distributed data via value-added experiences. Proacti incentivize 24/365 applications whereas turnkey total linkage. whiteboard multifunctional channels with interoperable value.
Professionally impact distributed data via value-added experiences. Proacti incentivize 24/365 applications whereas turnkey total linkage. whiteboard multifunctional channels with interoperable value.
