Regulatory Compliance Solutions pharmaceutical regulatory compliance

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Robust compliance frameworks tailored for regulated pharma environments

We help organizations establish and maintain GxP-compliant systems across manufacturing, quality, laboratory, and data processes. Our approach is based on current regulatory expectations from US FDA, EMA, MHRA, TGA, and Health Canada, ensuring systems are not only compliant on paper but also functional in daily operations.

Key Services Include:

• GxP system gap assessments and remediation
• Implementation of good documentation practices (GDP)
• Inspection readiness planning
• Internal audit system design
• Data integrity systems based on ALCOA+ principles
• Risk-based deviation and CAPA systems
• Regulatory mock inspections and readiness reviews

Outcome: A streamlined, audit-ready compliance system that ensures regulatory confidence and operational consistency.

Laying the foundation for sustainable quality and continuous improvement

A strong QMS is the backbone of any compliant pharmaceutical organization. We help companies develop, harmonize, and implement QMS elements that align with ISO 9001, ICH Q10, and global GxP standards—regardless of size or market.

Our QMS Implementation Support Covers:

• SOP development, harmonization, and approval workflows
• Policy and quality manual creation
• Document control system setup
• CAPA management and deviation tracking systems
• Change control procedures
• Training and competency matrix development
• Quality metrics and management review frameworks
   

Value Added: A structured and scalable QMS that fosters quality culture, improves traceability, and supports regulatory inspections.

Be prepared before regulators arrive — proactive audits for risk control and system improvement

We offer risk-based auditing services to assess system health, identify weaknesses, and ensure that your operations are continuously inspection-ready. Our audits are conducted by experienced professionals with deep knowledge of GMP, GLP, GCP, and data integrity requirements.

Audit Services Include:

• Internal audit program development and execution
• Third-party audits for vendors, CROs, and CMOs
• Technical due diligence audits (for partnerships/M&A)
• Mock regulatory inspections
• Compliance audits against EU/FDA/WHO standards
• Data integrity and ALCOA+ assessments
• CAPA follow-up and effectiveness checks
• Regulatory support for PAI, EMA GMP inspections, or Health Canada audits
   

Your Advantage: Identify gaps before inspectors do, correct risks proactively, and demonstrate robust quality ownership to regulators.

• PIC/S -  Pharmaceutical Inspection Co-operation Scheme - PIC/S Members 

• Argentina – ANMAT (National Administration of Drugs, Foods and Medical Devices)
• Brazil – ANVISA (National Health Surveillance Agency)
• Canada – Health Canada (Health Products and Food Branch – HPFB)
• Chile – ISP (Institute of Public Health)
• United States – US FDA (U.S. Food and Drug Administration)

• European Union – EMA (European Medicines Agency)
• United Kingdom – MHRA (Medicines and Healthcare products Regulatory Agency)

• India – CDSCO (Central Drugs Standard Control Organization)
• Indonesia – BPOM (National Agency of Drug and Food Control)
• Japan – PMDA (Pharmaceuticals and Medical Devices Agency)
• Malaysia – NPRA (National Pharmaceutical Regulatory Agency)
• Philippines – FDA Philippines
• Russia – Roszdravnadzor (Federal Service for Surveillance in Healthcare)
• Singapore – HSA (Health Sciences Authority)
• South Korea – MFDS (Ministry of Food and Drug Safety)
• Thailand – Thai FDA (Food and Drug Administration of Thailand)
• Vietnam – DAV (Drug Administration of Vietnam) 

• Iran – IFDA (Iran Food and Drug Administration) 
• Saudi Arabia – SFDA (Saudi Food and Drug Authority)
• Turkey – TMMDA (Turkish Medicines and Medical Devices Agency)
• United Arab Emirates – MOHAP (Ministry of Health and Prevention)

• Pan-Africa – AUDA-NEPAD (African Medicines Agency – AMA, emerging)
• Algeria – ANPP (Agence Nationale des Produits Pharmaceutiques)
• Botswana – BNMRA (Botswana Medicines Regulatory Authority)
• Burkina Faso – ANRPB (Agence Nationale de Régulation Pharmaceutique du Burkina)
• Cameroon – DPM (Direction de la Pharmacie et du Médicament)
• Côte d'Ivoire – DPM (Direction de la Pharmacie et du Médicament)
• Democratic Republic of the Congo – DPM RDC (Direction de la Pharmacie et du Médicament de la RDC)
• Egypt – EDA (Egyptian Drug Authority)
• Ethiopia – EFDA (Ethiopian Food and Drug Authority)
• Ghana – FDA Ghana (Food and Drugs Authority)
• Kenya – PPB (Pharmacy and Poisons Board)
• Malawi – PMRA (Pharmacy and Medicines Regulatory Authority)
• Mali – DPM (Direction de la Pharmacie et du Médicament)
• Morocco – DMP (Direction du Médicament et de la Pharmacie)
• Mozambique – ANARME (National Medicines Regulatory Authority)
• Namibia – NMRC (Namibia Medicines Regulatory Council)
• Nigeria – NAFDAC (National Agency for Food and Drug Administration and Control)
• Rwanda – Rwanda FDA (Rwanda Food and Drugs Authority)
• Senegal – DPM (Directorate of Pharmacy and Medicines)
• South Africa – SAHPRA (South African Health Products Regulatory Authority)
• Sudan – NMPB (National Medicines and Poisons Board)
• Tanzania – TMDA (Tanzania Medicines and Medical Devices Authority)
• Tunisia – DPM Tunisia (Directorate of Pharmacy and Medicines)
• Uganda – NDA (National Drug Authority)
• Zambia – ZAMRA (Zambia Medicines Regulatory Authority)
• Zimbabwe – MCAZ (Medicines Control Authority of Zimbabwe)

• Australia – TGA (Therapeutic Goods Administration)
• New Zealand – Medsafe (Medicines and Medical Devices Safety Authority)