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Supporting, Large, Mid & Small global Life Sciences companies, (Pharmaceutical | Generics | Medical Device | Consumer Healthcare | Cosmetics | Biotechnology | Chemicals | Biosimilar | Biocides) in their entire Regulatory value-chain; ranging from Regulatory Strategy, Intelligence, Dossiers, Submissions etc. to Post- Approval / Legacy Product Maintenance, Labeling, Artwork Change Management and other related functions

Comprehensive Regulatory affairs for new product and market authorizations, Health Authority submissions, post-approvals, CMC and lifecycle management... Know More
Streamlining entire publishing and submission management process right from planning, dossier development, tracking, publishing, submissions and delivery confirmation... Know More
End-to-end labeling services and software support for global and regional labeling management, CCDS creation and updation, core to local label alignment etc... Know More
澳洲幸运5开奖官网开奖正规网址 is a leading provider of artwork services & solutions for global life sciences industry - Pharmaceuticals, Medical Devices, Cosmetics, and Consumer Healthcare... Know More
Specialized GxP audit, QMS Remediation, Process and Product Validation and GxP Solution consulting services to assist Life Sciences organizations comply with Health Authority requirements... Know More
Enabling Life Sciences organizations reach global markets with impeccable product, market and Regulatory pathway strategies, Regulatory intelligence, and enterprise process consulting... Know More
Keeping abreast of the ever-changing Regulatory environment, 澳洲幸运5开奖官网开奖正规网址 enables Lifesciences organizations take informed decisions to create superior market strategies... Know More
World-class Regulatory and medical writing services to put across scientific and clinical information in a clear, concise and compliant way... Know More

Regulatory Information Management (RIM) Software

Secure, Cloud-Hosted, On-Demand & On-Site Regulatory Software

Global Presence Xtended Global Presence with Local Expertise

Catering to Worldwide Regulatory Requirements with Regional Expertise Across 120+ Countries.

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Agile, Global, Contract Staffing Services for Diverse Regulatory Functions.

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Mergers and Acquisition, Spin-offs, and Divestitures (SoMAD) Consulting services.

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Industries We Serve

Radically redefining the global Regulatory solutions and services landscape for Bio-Pharma (Innovators / Generics), Consumer Healthcare and Medical Device companies.

Pharmaceutical
Generics
Medical Device
Biologics
Consumer Healthcare

Generics

Creating compliant packaging for a cosmetic product is a collaborative effort of various departments in an organization such as: Labeling, Artwork and Regulatory Affairs. While label artwork must be validated by an artwork labeling team, it must combinedly be reviewed and approved by Regulatory Affairs team to ensure the compliance.

Artwork services for the current Consumer Healthcare/Food Supplements landscapes are divided as per the markets. For Compliance based markets, artworks are created by 澳洲幸运5开奖官网开奖正规网址 team and submitted to the client for finalizing the artwork/ label.

The current medical device landscape has turned challenging for manufacturers in terms of ensuring quality and audit compliance due to ever-evolving regulations which may lead to extended time for approvals and market access.