Regulatory Affairs

Have You Set The Right Course?

NovusLife can assist with the broad scope of regulatory requirements necessary to bring your idea to market and keep it available for patients - from discovery and preclinical evaluation through all phases of clinical development to approval, commercialization, advertising & promotion, post-marketing requirements and indication expansion. Our regulatory consultants are experts in strategic planning, evaluation of relevant regulatory precedent and guidance, conduct of pre-submission and clinical development meetings with the Agencies, preparation of compliant regulatory submissions, negotiation and navigation of regulatory roadblocks to move forward toward approval and compliance assessment for promotional activities and materials. NovusLife provides this regulatory life cycle management, domestically and internationally. We are focused on helping you when and how you need it.

Specific Services

Dossier/submission Preparation or Review and Filing Pre-Meeting Packages
INDs/CTAs/IDEs and Post-Filing Submissions
BLA/NDA/NDS/MAA/510(k)/PMA Filings
Development of Regulatory Strategy for the Product’s Life Cycle
Consideration of International Regulatory Requirements
Meeting International Filings
Revision of Plans as Guidelines Change
Facilitate Interaction with Regulatory Agencies
Liaison with Regulatory Agencies on Regulatory, Chemistry, Manufacturing and Controls (CMC), Clinical and Toxicology matters
Respond to Regulatory Agency Questions
Work with Regulatory Authorities through the Resolution of Complex Development Issues
Scientific and Medical Writing Services

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