Regulatory Affairs Consultancy

Navigating the regulatory landscape is a complex and ever-changing process. Our Regulatory Affairs Consultants have years of experience working with the FDA and other Regulatory bodies to ensure our clients products meet all necessary requirements for approval and commercialization. Our Regulatory experts provide strategic advice on Regulatory requirements, Risk Management, and Compliance throughout the Product Lifecycle. We help clients develop comprehensive Regulatory Strategies that meet their specific needs and ensure timely approvals.

Regulatory Strategy 

o   Medical Devices

           ▪         Develop Regulatory Roadmap from Concept to Launch.

           ▪         Pre-sub meetings with Agencies.

           ▪         LTE, IDE, 510 (k), and PMA support.

           ▪         CE certificates, Import/Export support.

           ▪         Change notification to Notified Body, Reportable events.

           ▪         Facility and Product registrations

           ▪         EU Representative support

           ▪         Technical file Development and Review

           ▪         Post-market Surveillance reports- PSURs, PMCFs, PMS activities- Competitive 

                 Landscape

           

o   Drugs/Biologicals

           ▪         Regulatory submission Strategy from Concept to Launch.

           ▪         Regulatory compliance consulting to address agency queries.

           ▪         CMC Consulting support for preparation/submissions of INDs, NDAs, ANDAs. BLAs, etc.

           ▪         Post approval change submissions like change in manufacturing sites, formulation 

                  or batch size change, the addition of new API supplier, specification/analytical 

                  method change, change in container/closure system, shelf-life extension, or reduction.

           ▪         505(b) 2/Dossier preparation and submission.

Communication to Regulatory Authorities 

   o   Medical Devices 

           ▪         Pre-sub meetings

           ▪         Response to 483s

           ▪         Consent Decree & Warning letters response support

           ▪         Discussions with Regulatory bodies.

   o   Drugs/Biologicals

           ▪         Pre-sub interaction with agencies.

           ▪         Response to 483s.

           ▪         Consent Decree & Warning letters response support.

           ▪         Discussions with regulatory bodies.

Regulatory Remediation 

o    Medical Devices

           ▪         Audit readiness

           ▪         Consent Decree

           ▪         Warning letters

           ▪         Documentation Remediation for compliance


o    Drugs/Biologicals 

           ▪         Audit readiness

           ▪         Consent Decree

           ▪        Warning Letters 

           ▪         Documentation Remediation for compliance