MK Pharma Solutions
Regulatory CompliancePharmaceutical Quality SystemsGMP Audits & Inspection ReadinessValidations and QualificationsContamination Control Strategy (CCS)Technology TransferProduct & Regulatory SupportPharmaceutical Project EngineeringRegulatory CompliancePharmaceutical Quality SystemsGMP Audits & Inspection ReadinessValidations and QualificationsContamination Control Strategy (CCS)Technology TransferProduct & Regulatory SupportPharmaceutical Project Engineering
Our Services

IntegratedExpertiseAcrossthePharmaceuticalLifecycle

From regulatory strategy to commercial readiness — we provide the full spectrum of pharmaceutical consultancy services.

MK Pharma Solutions provides end-to-end regulatory and compliance support — from CTD dossier preparation and product information updates (SmPC, PIL & Labelling) through pharmacovigilance reporting, dossier audit with risk assessment grading, global product registration, and sourcing consultation for registration services across regions.

Our structured regulatory workflow covers the full CTD module framework (Modules 1–5), ensuring every submission is audit-ready, risk-graded, and aligned with the evolving expectations of global regulatory authorities.

Regulatory Gap Assessment

Comprehensive assessment of facilities, systems, processes and documentation against applicable regulatory requirements and industry expectations.

GMP Compliance Programs

Development and implementation of structured compliance programs addressing identified regulatory and operational gaps.

Regulatory Inspection Readiness

Preparation of pharmaceutical facilities and personnel for regulatory inspections and customer audits.

Audit Support

Support before, during and after regulatory inspections, customer audits and due diligence assessments.

Compliance Remediation

Development and implementation of corrective action and remediation programs addressing audit observations, regulatory findings and systemic quality deficiencies.

Pharmaceutical Quality System Development

Establishment and strengthening of quality systems covering Change Control, Deviation Management, CAPA, Quality Risk Management, Document Control, Training Management, Supplier Qualification, Internal Audits, Management Review, Product Quality Review, Data Integrity, and Validation Lifecycle Management.

Global Regulatory Compliance

Support for facilities operating under requirements and expectations established by applicable global regulatory authorities and recognized GMP frameworks.

Regulatory Workflow Overview
CTD Module Framework & Regulatory Process Flow
Regulatory workflow diagram showing CTD modules 1–5 alongside five key process steps: Product information updates (SmPC, PIL and Labelling), Patient Safety Update Report and Pharmacovigilance Report and Risk Management Plan, Dossier Audit with Risk Assessment grading, Product registration support in various countries across the globe, and Sourcing of consultation for registration services at various regions through known firms.
Product Information Updates (SmPC, PIL & Labelling)Pharmacovigilance & Risk Management PlanDossier Audit with Risk Assessment GradingGlobal Product Registration SupportConsultation Sourcing for Registration Services
Get In Touch

Ready to Discuss Your Requirements?

Contact our team to explore how we can support your pharmaceutical project or compliance objectives.

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Branch 1

Hosur, Bengaluru – 635109

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Branch 2

Hyderabad, Telangana 500092