Everything About Cliniexperts - A 360 Degree Global Regulatory Service/solution Expert

By Author: CliniExperts Pvt Ltd
Total Articles: 5
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Regulatory bodies of different countries are government authorities that ensure the safety of the products entering the market before becoming accessible to the consumers. These regulatory bodies manage, scrutinize, steer, and manage sectors like the food, drug, and cosmetics industry.[1]
The process of regulatory approval after innovation and designing a new product can be complex for a manufacturer or importer. As a result of the strict regulations, the successful launch of new products into the market can be delayed.[2]
To overcome these problems faced by the manufacturers and importers from several fields, CliniExperts offer services that help to smoothen the product’s approval.[2] CliniExperts is regulatory affairs agency in India that eases product entry into the market.[3]
With its stringent standards for product’s quality control and quality assurance, meritocracy, latest information, beyond doubt ethics, and rectitude professionalism, CliniExperts functions as a bridge to help their clients through various processes of regulatory approval compliance.[3]
Founded in 2009 and based in the ...
... country’s capital, New Delhi, CliniExperts helps speed a product's entry into the market, thereby contributing to a safer and healthier society.[1]
The strategies planned by professionals of CliniExperts provide an excellent viewpoint because of the in- depth knowledge about the laws and regulations for the product's development, testing, approval, manufacturing, commercialization and post-marking surveillance for the different global markets.[3]

360 Regulatory Solutions For Indian Market

CliniExperts assists their clients throughout their journey by providing 360 regulatory services for the Indian market in concern with different government authorities.
These include Central Bureau of Narcotics, National Pharmaceutical Pricing Authority, Indian Council of Medical Research, Food Safety and Standards Authority of India, Directorate General of Foreign Trade, Department of Scientific and Industrial Research, Central Drugs Standard Control Organisation, and Department of Telecommunications.[3]

Regulatory services for India
Drug
Phytopharmaceutical Drug
Cosmetic
Cosmetics Importer
Narcotics regulatory affairs
Diagnostic kit
Medical devices
Food – FSSAI
Nutraceuticals
Vaccines
Biologicals
Biological Sample – ICMR
Contract Research Organization
Wireless Planning and Coordination
Legal Metrology
Authorized Agent/Registration Holder
Table 1: Regulatory Affairs Services in India from CliniExperts.[2]

*ICMR= Indian Council of Medical Research; FSSAI= Food Safety and Standards Authority of India
With the years of expertise, networking, and collaborations, CliniExperts provides 360 regulatory services for Indian market in the following ways:
1. Regulatory intelligence and strategy
2. Authorized agent/registration holder support
3. Distributor identification
4. Distributor point.[1]

360 Regulatory Solutions for Global Market
Entry of pharmaceutical products into vast and emerging markets of the European Union (EU), the United States of America (USA), and the African subcontinent can be challenging for the manufacturer or importer because of varied guidelines in these countries.[2]
For such manufacturers and importers who wish to launch their product in the global market, CliniExperts also provides global regulatory services.[2]
CliniExperts professionals help in product’s life cycle management right from its journey of development to launch by defining regulatory strategies specific to the country. A comprehensive understanding of the market helps to iron out potential roadblocks in the approval process.[2]
CliniExperts is a global regulatory solutions and services company, which helps designs strategy for the product as per the market, prepares and files all the documents required by the health authorities of the semi-regulated and regulated markets, and post-approval changes.[4]
A strategic, in-depth, and comprehensive planning and blueprint preparation for filing regulatory dossiers ensures no obstacles ant any step for launching the product.[4]
Based on the product’s data, CliniExperts help to select the geographical regions where the client can register their dossier. Along with choosing a regulated or semi-regulated market, CliniExperts also assist in reducing the timelines for placing the products into export.[4]
For the pre-registration services, CliniExperts provide assistance in data generation and quality and regulatory compliance backed up by gap analysis and expert reports.[4]
For the registration process of the product, they provide support for the preparation, review, and submission of Drug Master File, registration of dossier, preparation of technical and administrative documents, and handling query responses.[4]
In post-approval changes, CliniExperts aids in planning, preparation, and submission of additional documents required by the country's regulatory body where the product is launched.[4]
In this process of making minor, major, or critical changes, CliniExperts are the global regulatory experts that help generate additional data for the product.[5] Additionally, they also assist in the extension of shelf-life or labels.[4]

Conclusion
With the years of expertise, networking, and collaborations, CliniExperts offers a complete bouquet of solutions for regulatory affairs and focuses on helping their clients in the launch of products in Indian and global market.

Image credit: https://pixabay.com/de/illustrations/nachrichten-gesetz-global-hammer-6585574/

References:
1. CliniExperts. India regulatory services [Internet]. Available at: https://cliniexperts.com/india-regulatory-services/. Accessed on Nov 18, 2021.
2. CliniExperts. CliniExperts – Scientific, systematic and synergistic [Internet]. Available at: https://cliniexperts.com/about-company/. Accessed on Nov 18, 2021.
3. CliniExperts. CliniExperts [Internet]. Available at: https://cliniexperts.com/. Accessed on Nov 18, 2021.
4. CliniExperts. Global regulatory services [Internet]. Available at: https://cliniexperts.com/global-regulatory-services/. Accessed on Nov 18, 2021.

CliniExperts is an Indian and global regulatory solutions provider catering to a vast array of services lines and products to simplify, familiarize and support our clients through every step of the regulatory process. CliniExperts offers 360 degree regulatory solutions to – Pharmaceutical, Food, Nutraceutical, Cosmetic, Medical Device, Diagnostic Kits, Biologicals and Vaccine Industry.