Global Regulatory Affairs Experts

Our Expert Consultant’s team will take care of the burden and intricacies associated with managing Regulatory, Quality, Safety, and Data Management activities. Our main office is based at London, UK and we have a team of consultants based at London, Mumbai and other remote locations.

  • Regulatory Affairs EU/UK/Global

  • MAAs, CTAs, IMPD/IND

  • Post-approval life cycle maintenance

  • CMC and CTD/eCTD Dossier Build

  • Vaccines/Brexit/Labelling

  • Pharmacovigilance

  • Clinical Trials, BABE Studies, Monitoring,

  • Pre-Clinical Studies,

  • Analytical testing

  • Bio-waiver Study (In-vitro/In-vivo Correlation)

  • Project Management

  • Analytical Testing

Our Services

We, at RegVision Consulting Ltd are a team of seasoned specialists with a profound knowledge and expertise on the regulatory intricacies of the US, EU-UK and the Global pharmaceutical/biotech arena.

Our mission is to provide a bespoke consultancy services that empowers our clients to secure, maintain, and excel in their product licensing endeavours.

Please refer to our website for a range of consultancy and partnership services that we can customise for your business and also feel free to be in touch for more understanding about how we can meet your business needs.

    • At RegVision Pharma Consulting, we offer end-to-end strategic consulting for pharmaceuticals/biotech.

    • From discovery to regulatory approval, our experienced team handles it all.

    • We excel in pre-registration assessments, submission preparation, compliance reviews, and managing interactions with Health Authorities for successful approvals in the US and EU.

    • We understand the industry-wide challenge of managing submissions, maintenance, post-registration tasks, and product launches.

    • Keeping an expert in-house team is difficult due to the evolving regulatory landscape.

    • We offer a comprehensive solution to handle these tasks, including variations, renewals, labelling changes, safety submissions, and database maintenance, ensuring ongoing regulatory success.

    • We offer compliant CMC (Chemistry, Manufacturing, and Controls) dossier development across diverse industries, including pharmaceuticals, biotechnology, vaccines, and ATMP/GTMP. Our services range from initial marketing authorization applications to thorough dossier authoring for compliance analysis. Our experts handle Drug Substance, Drug Product, Analytical, and administrative dossier sections, following ICH-CTD standards or your templates.

    • Additionally, we provide tailored Change Control solutions using systems like TrackWise or Veeva Vault, including initiation, impact assessment, and precise tracking.

    • Our consultancy team manages Module Certificates and Statements, covering GMP, MLs, CEPs, CPPs, ASMF/DMFs, LoAs, PoAs, and country-specific requirements. Count on us for comprehensive CMC expertise tailored to your specific needs.

“With our dedicated team by your side, achieving and maintaining Regulatory Compliance becomes a seamless journey. Focusing on you, for better health.”

Dr Mark Fletcher - Advisor, Co-Founder, Director

Get in Touch

At RegVision, our aim is to help support you achieve your vision to stay compliant with your Regulatory, Clinical, Pharmacovigilance and Quality requirements. We provide bespoke consultancy services to suit your organisation’s requirements.