Regulatory Compliance
In today’s worldwide regulatory compliance for the product is a must for the approvals, MAVEN’s Regulatory research division has experts who can map regulatory compliance requirements of different geographies to different products with expertise across USA, Canada, Mexico, Europe, Australia, South Korea and Japan, MAVEN solves our client’s toughest challenges by providing services
- Local Regulatory Affairs
- Product dossier preparation and gap analysis
- Market Access and Regulatory Strategy
- Regulatory Intelligence
- Product Authorization
- Regulatory/Medical Writing, Publishing and Submissions
- Regulatory Labeling, Artwork, Registrations, CMC, QA Services specified to Medical Devices, Pharmaceuticals/Drugs, Cosmetics,Biologics/ Biosimilars, Nutraceuticals, Electrical and Electronics, Toys, Textiles & Retail, Chemicals & Implants.
Gap Analysis
MAVEN Reports
Publishing and Submissions
Our team is expertise in performing different types of Publishing and Submission activities, Our services include:
Regulatory Labeling
Expertise in providing tailor made labelling services for different needs of customers, our expertise include the following:
Artwork and Pack Management
Our services include carton, private labeling and primary and secondary packaging, we provide innovative, attractive and compliant design and artwork for our clients
Regulatory Writing
eCTD Module 1 to 5
Product Registrations and Market Authorizations
To commercialize a product in a specific region, organizations must obtain market authorization from target country’s industry specific Regulatory Authority, which can be processed by filing an initial submission application. Any application products submitted to a Regulatory authority for the first time, with supporting documents/data in-line with geo-specific requirements, is considered as new/initial/original submission. MAVEN has a very strong Regulatory team having prior experience and expertise in handling market authorizations of all major Regulatory Authorities of different countries
Quality Management System compliance for Manufacturers
Local on-the-ground Presence in USA, Canada, Mexico, Europe, Australia, South Korea and Japan
In today’s worldwide regulatory needs, MAVEN’s Regulatory research division has experts who can map regulatory requirements of different geographies to different products.
With expertise across USA, Canada, Mexico, Europe, Australia, South Korea and Japan, MAVEN solves our client’s toughest challenges by providing services:
- Local Regulatory Affairs
- Market Access and Regulatory Strategy,
- Regulatory Intelligence,
- Product Authorization.
- Regulatory/Medical Writing, Publishing and Submissions
- Regulatory Labeling, Artwork, Registrations, CMC, QA Services specified to Medical Devices, Pharmaceuticals/Drugs, Cosmetics, Biologics/ Biosimilars, Nutraceuticals, Electrical and Electronics, Toys, Textiles & Retail, Chemicals & Implants.
