Global regulatory affairs experts

Remove the burden and intricacies associated with managing regulatory, quality, safety, and data management activities.

Our Services

We are seasoned specialists with a profound focus on the regulatory intricacies of the UK, EU, and the global pharmaceutical arena.

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

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

    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 submission, 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 premium 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 compliance becomes a seamless journey. Focusing on you, for better health.”

— Rajbir Mason

Get in Touch

At RegVision our aim is to help support you achieve your vision to stay compliant with your Pharmacovigilance, Regulatory and Quality requirements.