Services

Pharmaceutical and Dietary Supplements Products

1. Product classification and regulatory pathway assessment for pharmaceutical and dietary supplement products.
2. Regulatory strategy, market access planning, and applicable regulatory requirements assessment.
3. Regulatory dossier preparation, technical documentation review, gap assessment, and submission readiness support.
4. Product registration, re-registration, renewal, variation, and regulatory lifecycle management support.
5. Regulatory E-System account setup guidance, submission coordination, and application follow-up support.
6. Product labelling, artwork, claims, ingredients, and regulatory compliance review.
7. Certificates of Analysis (CoA), product specifications, methods of analysis, quality documentation, and laboratory requirements review.
8. Manufacturer and establishment regulatory documentation review and applicable registration requirements advisory.
9. Import documentation, regulatory clearance requirements, and supply chain compliance advisory.
10. Regulatory intelligence, compliance monitoring, and ongoing regulatory advisory support.

Cosmetics & Personal Care Products

ReguHealth provides specialized regulatory consulting support to manufacturers, brand owners, importers, and distributors in the cosmetics and personal care sector. Our services cover product classification, registration and notification pathways, formulation and ingredient compliance, labelling and claims assessment, and technical documentation, supporting regulatory compliance and market access across Qatar, the GCC, and regional markets.

1. Product Classification and Regulatory Assessment: Assess product formulations, ingredients, intended uses, and claims to determine regulatory classification, applicable registration, listing or notification pathways, and technical requirements.
2. Regulatory Accounts and E-Systems: Assist with establishing, activating, and updating company and establishment accounts on regulatory platforms, including preparation, management, and follow-up of electronic submissions.
3. Product and Establishment Registration: Support the preparation, submission, and follow-up of product registration, listing or notification applications, as well as relevant company, manufacturer, and establishment registration requirements.
4. Formulation and Technical Compliance Review: Assess ingredients, concentrations, prohibited and restricted substances, product specifications, technical documentation, and applicable product safety requirements.
5. Cosmetic Labelling and Claims Compliance: Prepare and review regulatory labelling content, ingredient lists, mandatory information, cosmetic and marketing claims, and supporting substantiation.
6. Technical Documentation, Import and Clearance: Review product documentation, including Product Information Files (PIF), safety assessment reports where applicable, Certificates of Analysis and Conformity, and supporting documents, with advisory support for import, inspection, and regulatory clearance requirements.
7. Ongoing Compliance and Change Management: Provide advisory support on formulation, labelling, and specification changes, regulatory observations, non-compliance assessments, corrective actions, and ongoing compliance requirements.

Import and Supply Chain Regulatory Support

ReguHealth provides regulatory consulting and technical support to help businesses navigate importation requirements, shipment documentation, regulatory clearances, and supply chain compliance for regulated products.

Our support includes pre-shipment regulatory requirements assessment, review of commercial and technical shipping documents, verification of product registration and labelling compliance, identification of potential documentation discrepancies, and advisory support for regulatory clearance and product release procedures.

We help manufacturers, importers, and distributors identify regulatory risks early, improve shipment documentation readiness, and facilitate compliant and efficient product movement across target markets.

Pharmacovigilance and Specialized Regulatory Services

ReguHealth provides specialized regulatory and technical consulting support to pharmaceutical companies, Marketing Authorization Holders (MAHs), and healthcare organizations in addressing pharmacovigilance, product safety, and regulatory compliance requirements. Working with qualified professionals and specialist partners, we provide tailored advisory solutions to support product safety monitoring, risk management, and ongoing regulatory compliance across target markets.

1. Pharmacovigilance Systems and Compliance: Support the establishment, development, and review of pharmacovigilance systems, Standard Operating Procedures (SOPs), and related regulatory documentation, including Pharmacovigilance System Master Files (PSMFs), where applicable.
2. Safety Reporting and Adverse Drug Reactions: Provide technical support for the collection, assessment, and processing of adverse drug reaction reports, and the preparation and review of Individual Case Safety Reports (ICSRs), Periodic Safety Update Reports (PSURs), and Periodic Benefit-Risk Evaluation Reports (PBRERs), in accordance with applicable regulatory requirements.
3. Safety Surveillance and Risk Management: Support safety signal monitoring and evaluation, preparation and review of Risk Management Plans (RMPs), risk minimization measures, and post-marketing safety activities.
4. Advanced Regulatory and Technical Services: Provide specialized consulting support for Chemistry, Manufacturing and Controls (CMC) documentation, technical and regulatory dossier reviews, gap assessments, and regulatory variations. Additional capabilities, coordinated through qualified specialists and partners, may include Regulatory Information Management Systems (RIMS), regulatory publishing, readability assessment, and user testing.
5. Regulatory Compliance Review and Assessment: Assess compliance with applicable regulatory requirements, review regulatory gaps and authority observations, and provide recommendations for corrective and continuous improvement actions.
6. Training and Capacity Building: Provide specialized training programs and workshops in pharmacovigilance, drug safety, regulatory compliance, and risk management, in collaboration with qualified professionals where appropriate.