Pharmaceuticals

Overview

Medwisdom Lifescience is a premier provider of regulatory services, equipped with extensive experience and expertise in managing various phases of drug, vaccine, and biosimilar registration. From initial development to dossier gap analysis, preparation, submission, and lifecycle management, Medwisdom delivers comprehensive regulatory solutions as  per the client needs.

Expertise

Our regulatory services involes all stages of drug development, including: 

– Development Stage: Comprehensive regulatory planning and support during the development phase. 

– Pre-Submission Administrative Activities: Ensuring smooth documentation and coordination for regulatory filings. 

– Regulatory Assessment and Gap Analysis: Identifying compliance gaps and aligning with regulatory requirements. 

– Regulatory Document Authoring: Preparation of high-quality submissions to meet regional and global standards. 

– Compilation, Review, and Submission: End-to-end handling of dossiers to ensure timely submissions. 

– Responding to Health Authority Queries: Providing precise and prompt responses to regulatory authority inquiries. 

– Post-Approval Submissions: Facilitating smooth regulatory processes for  post-approval changes. 

– Lifecycle Management Services: Ongoing support to maintain compliance throughout the product’s lifecycle. 

Advantages

– Optimum cost without compromising quality. 

– Comprehensive Regulatory Support

– Qualified and Experienced Team

– Region-Specific Expertise

– Direct interaction and negotiation with regulatory bodies for faster approvals. 

– Structured processes to accelerate product launches and ensure smooth market entry.