Regulatory Affairs Consulting Services: Pharma & Medical Device Registration

Let us assist you in obtaining approval for medical device registration and new pharmaceutical products, ensuring that your company maintains authorization and remains compliant in the pharmaceuticals market.

What is Regulatory Affairs ?

Regulatory affairs manage the processes required to obtain approval and ensure compliance with local regulations. Whether it involves pharmaceutical product or medical device registration, or the launch of a new supplement, they work to protect public health and ensure safety by enforcing strict laws on medical and pharmaceutical companies.

Medisyncglobal

Regulatory affairs manage the processes required to obtain approval and ensure compliance with local regulations. Whether it involves pharmaceutical product or medical device registration, or the launch of a new supplement, they work to protect public health and ensure safety by enforcing strict laws on medical and pharmaceutical companies.

We supports clients in managing their day to day regulatory work as per services offered below:

Pre-licensing activities such as dossier submission to local health authority, review of dossier to align to local regulatory requirements, liasion support for regulatory submission cycle.

Post-licensing activities such as renewal, variations, change notifications, market recall activities.

Regulatory support in daily operations work ( link to regulatory subscription plan)

Licence holding

Consulting for regulatory advices.

Artwork and marketing materials review

Why Choose Us?

Since every project and client situation is unique, we offer a customized package of services to meet the specific needs of each application.

Expertise

Benefit from our years of experience in regulatory affairs across various industries, including pharmaceuticals, medical devices, biotechnology, and more.

Hassle-Free Process

Our regulatory consulting services meticulously review and strategise every aspect of your regulatory affairs to ensure a smooth sailing approval process.

Speedy Approach

Time is of the essence, so we work to help you bring your products to the market faster without compromising on quality or compliance.

Comprehensive Support

From initial assessments to ongoing compliance maintenance, our consulting services cover the entire spectrum of regulatory affairs for comprehensive support at every stage.

If you have any enquiry, please do not hesitate to contact us..

Composed of proven experts from the pharmaceutical industry, our team is ready to answer to your needs in any area of product development, commercialisation and early access programs, and life cycle management.

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