Our Mission
01
Committed Service
To provide superior consulting services in pharmaceuticals.
02
Industry Expertise
Delivering tailored solutions to pharmaceutical sector challenges.
03
Client Success
Guiding our clients towards sustainable growth and efficiency.
OUR EXPERTISE
GMP services
We provide comprehensive GMP compliance support for manufacturers worldwide. Our services include GMP audit preparation, gap assessments, documentation review, mock inspections, and hands-on readiness for certification by Worldwide authorities. Whether you’re building a new facility or upgrading existing operations, we guide you through every step to meet Good Manufacturing Practice standards.
GDP services
Our GDP specialists assist pharmaceutical distributors and logistics providers with achieving and maintaining compliance with Good Distribution Practice. We support wholesale distribution license applications, warehouse qualification, temperature mapping, SOP development, and Responsible Person (RP) training. Our goal is to ensure your supply chain operates with full regulatory integrity.
Regulatory Affairs
From dossier creation through product registration to lifecycle maintenance, we offer strategic and operational support in Regulatory Affairs. Our expertise includes national and EU procedures (DCP, MRP, CP), FDA submissions as well as ROW submissions, eCTD dossier compilation, variation management, and interactions with EU regulatory agencies. We ensure your submissions are complete, compliant, and on time.
Other services: Pharmacovigilance, Project management, Market Access
We support Marketing Authorization Holders (MAHs) with LQPPV and QPPV services, risk management planning, safety data review, and audit preparation. We ensure your PV system meets all legislative and GVP requirements.
We provide expert project management for regulatory, GMP, and market access initiatives. Our experienced team ensures efficient planning, stakeholder coordination, and on-time delivery of critical milestones. Whether launching a product or implementing a new compliance system, we keep your project on track.
We support your entry into Worldwide markets through pricing and reimbursement strategies, HTA dossier preparation, and local market analysis. Our tailored market access solutions help you maximize commercial success while ensuring compliance with national requirements and payer expectations.
Quality Focus
We prioritize quality assurance in every step we take.
Ensuring compliance with global standards and regulations.
50+ GMP clients
500+ Agency inspections
100+ MAs granted
Robust Systems
Continuous Improvement
Client Trust