Canada/UK/Emerging Market

Canada Regulatory Market Support

Regulatory Gap Analysis 
Identifying differences between Canadian regulatory requirements and existing US/EU dossiers to ensure compliance with Health Canada’s regulations.

Drug Identification Number (DIN) Application 
Assisting in obtaining a DIN, mandatory for marketing pharmaceutical products in Canada.

Drug Establishment License (DEL) 
Supporting clients in obtaining a DEL, required for importing, manufacturing, testing, and distributing drugs in Canada.

Generic Drug Product Submission 
Preparing and submitting Abbreviated New Drug Submissions (ANDS) for generic drugs, including eCTD dossier preparation, regulatory strategy, and Health Canada interactions.

UK Regulatory Market Support

At RGInsight, we offer end-to-end regulatory and compliance support tailored to the UK pharmaceutical landscape. Our services are designed to help companies navigate post-Brexit regulatory frameworks efficiently and compliantly.

MAH Services in the UK
Acting as Marketing Authorization Holder or supporting existing MAHs for seamless product maintenance and regulatory communication with the UK MHRA.

UK MHRA Inspection Coordination
Support in inspection readiness and management of inspection triggers raised by the UK MHRA, ensuring proactive compliance and corrective actions.

QP (Qualified Person) Support
Access to experienced QPs for batch certification, release, and technical oversight—aligned with UK GMP requirements.

Regulatory Fees Submission
Assistance in timely and accurate submission of regulatory and application fees to the MHRA.

Batch Release & Testing Site Support
Coordination with UK-based testing labs and release sites to ensure full GMP and GDP compliance for imported or locally manufactured products.

Wholesaler/Distribution Support
Liaison with MHRA-compliant wholesale dealers for storage, distribution, and supply chain integrity.

Dossier Writing & Submission (MHRA-Compliant)
CTD dossier preparation, adaptation, and submission in accordance with UK MHRA requirements, including variations and renewals.

Pharmacovigilance (PV) System Setup
Full PV system establishment tailored to UK expectations, including a UK-based QPPV, PSMF localization, and ICSR handling.

Emerging Markets Regulatory Support

Market Authorization Applications
Strategic preparation and submission of dossiers to health authorities for pharmaceuticals and biologics.

Multi-Regional Dossier Applications
Specialized support for dossier compilation and submission across CIS, LATAM, ASEAN, AFRICA, MENA, and GCC regions.

Dossier Audits & Gap Analysis
Comprehensive technical and regulatory audits to identify deficiencies and ensure dossier readiness.

Compliance Gap Identification & Resolution
Targeted strategies to address country-specific regulatory gaps before submission, reducing the risk of rejections.

Deficiency Response Management
Timely, well-justified responses to authority queries to keep your approvals on track.

Product Registration Services
End-to-end support in managing complex global registration procedures—ensuring accuracy, speed, and compliance.

Regional Expertise & Local Support
Region-specific guidance from experts familiar with local regulatory landscapes and authority expectations.

Dossier Reformatting & Regulatory Submissions
Reformatting and adapting existing dossiers to meet regional submission formats and regulatory standards (e.g., eCTD, ACTD).