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Personalized seamless delivery of projects

Well known for timely delivery of project, which keeps our client ahead of market while step into foreign regulatory business

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Decoding for recent updates of Regulatory Authorities

Regulatory Authorities are being stringent and updating the regulations very frequently. Understanding the changes and initi

Need In sights for taking informed decisions

Submissions in Stringent Regulatory Authority

SRA approval status make a real difference in market while opens door for world wide supply.

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Product Development, Launch and full Life cycle Services

Artwork & layout reviews, Leaflet writing, Medical Blogs writing, Product launching marketing material drafting

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About Us

Wide Portfolio

Oxylrev is Global Regulatory value chain service provider with total end to end solution.
Oxylrev is a collection of diversified portfolio services specifically designed to match current market needs for Pharmaceutical clients, biotech industries, food and cosmetic segment, API manufacturers, Medical and consumables manufacturers, distributors.
Oxylrev is committed to give service in diversified product portfolio with different regional requirements of rules and regulations , in country supports for securing private and public market products portfolio.

build your market

In -Time delivery

Time is considered as a winning factor, as it impacts clients Market position in global exposure.
Oxylrev always respects deadline projects to meet ambitions of client’s crucial projects.
Our high Customer Satisfaction Index reflects continued consistent performance. We deliver beyond restrains of existing boundaries of client.

Need Speedy dossier filing

Global Standards

Oxylrev is following global standards for product filing, labeling, and data exchange for pharmaceuticals, medical devices, APIs.
Other parallelly evolving sectors of hospital equipment, neutraceuticals, herbal cosmetics, consumables.
The constant referencing of the global resources are made us always up to date with current standards of technical guidance on how to comply with future regulatory stringency to stands as most efficient player in the market.

New market for you? tell us

Core Competencies

Dossier Writing : Common Technical Document (CTD) , compliant to ICH guideline and stringent regulatory Authorities like USFDA, MHRA.
ACTD (Asian Common technical Dossier) submission in Asian regions: Philippines, Thailand, Malaysia, Venezuela whole Asian territory.
NDA applications, ANDA application, Pre market approval submission as per US-FDA standards.
WHO Pre Qualifications applications and Approvals
Dossier submission in emerging potential countries like Latin America, South east African region, FMHACA Ethiopia submissions, SADC submissions, UEMOA submissions, ZAZIBONA submission in semi regulated market.
Medical devices guidelines and Standard Table of contents formatted templates for marketing authorization submission in regulated authority.
Consumables and reusable Medical devices filing USFDA, TGA, MHRA, Asian territory and semi regulated countries like UEMOA region, English African countries Ethiopia, Zambia, Tanzania, Frencho-phone regions: Burkina Faso, Cameroon, Mali, Congo RD etc.
Neutraceuticals product dossier filing in brand name marketing permissions.
Hospital Equipments marketing authorization filing with various model specifications
Standard Operating Procedure writings for Pharmacovigilence and risk assessment methodology
Art work approvals as per labeling requirements and instructions for use preparation and proof reading.
Extending vigorous efforts and direct support on facing plant site audits from authorities like FMHACA, TGA, USFDA, WHO, TFDA, ZAMRA, LMHRA etc.

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Current changes in Regulations of various Regulatory Authorities are being tracked and implications have been studied, Changes needs to be decoded to get it implemented in execution level.

Need training or need to organize training for your employees?

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Our Services

New Product Dossier submissions: Finished pharmaceutical Products
Active Ingredients : New Approval applications
DMF writing
Renewal application filing
Product launching and targeting market strategy
Queries response submissions
Regulatory Post market surveillance
Product development reports writing
Post market surveillance report.
Stability Protocol designing, Validation Protocol designing.
Product variation filing
Identifying Potential market and Product development
Proof reading and writing of patients Information leaflets/SPCs
Product layout and Art work development
Dossier submission for medical devices
Neutraceuticals product Authorization
Herbal and Cosmetics products marketing authorization
Hospital equipment authorization licensing and approvals
Audit compliance technical support and response submissions for observations
Site Master file submissions, arranging site audit plan and executions
WHO PQ filing
Tender filing for public supply, hospital supply

What is your product marketing plan? need marketing authorisation?

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Send us your Requirements in Brief.

Do you feel need to book for primary discussion session? We offer a broad range of services and packages that be customized to your needs. Send us a message today, and we can start you on a path to success.

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Oxylrev Solutions

What's App : + 91 8866045790 Email: info.oxylrevsolutions@gmail.com