TajMedico is a globally oriented pharmaceutical company with a strong regulatory framework and advanced manufacturing capabilities. The organization is supported by a highly skilled Regulatory Affairs (RA) division that ensures all products comply with international standards and country-specific requirements. With a focus on quality, safety, and regulatory precision, TajMedico successfully serves regulated and semi-regulated markets across multiple continents.

Regulatory Affairs (RA) Excellence at TajMedico

The Regulatory Affairs department plays a critical role in ensuring smooth product approvals, market authorization, and lifecycle management.

Key Responsibilities:

Global Regulatory Compliance:
TajMedico maintains alignment with global authorities such as USFDA, EMA, MHRA, TGA, WHO-GMP, ANVISA, and other national regulatory bodies. Continuous monitoring of regulatory updates ensures full compliance with evolving guidelines.

Dossier Preparation & Submission:
Expert teams prepare CTD, eCTD, and ACTD dossiers with complete documentation covering quality, safety, and efficacy data. The department handles new product registrations, renewals, and variations efficiently.

Regulatory Strategy Development:
Strategic planning is implemented to accelerate product approvals and reduce time-to-market. Strong coordination with health authorities ensures smooth regulatory pathways.

Labeling & Packaging Compliance:
All product labeling, artwork, and packaging materials are developed in accordance with country-specific regulations. Multilingual labeling is supported for global distribution.

Audit & Inspection Readiness:
TajMedico maintains complete readiness for inspections by WHO, EU GMP, and other regulatory bodies. Documentation systems are designed to support transparent and traceable compliance.

Electronic Submissions:
Advanced digital systems are used for eCTD submissions, regulatory publishing, and document lifecycle management, ensuring faster approval processes.

Manufacturing Excellence – OSD & External Preparation Facilities

TajMedico operates world-class manufacturing units designed according to WHO-GMP and international standards.

Oral Solid Dosage (OSD) Facility

The OSD unit is dedicated to manufacturing tablets, capsules, granules, and pellets.

Capabilities Include:

  • Immediate, sustained, and controlled-release tablets
  • Hard gelatin and softgel capsules
  • Granules and sachets for oral administration

Facility Strengths:

  • Fully automated production lines
  • Controlled cleanroom environments with HEPA filtration
  • Advanced granulation, compression, coating, and packaging systems
  • Pilot to large-scale commercial batch production

Quality Systems:

  • In-house QC laboratory with HPLC, UV, dissolution, and stability chambers
  • Strict adherence to ICH stability guidelines
  • Fully validated processes and documentation systems

External Preparation (Topical) Facility

This division specializes in dermatological and topical formulations.

Product Range:

  • Creams, ointments, gels, lotions
  • Medicated shampoos and antiseptic solutions
  • Cosmetic and therapeutic skin formulations

Key Features:

  • Dedicated production zones for semi-solid formulations
  • High-shear mixers and homogenizers for uniform consistency
  • Controlled microbial environments with regular monitoring
  • Flexible packaging options including tubes, jars, and bottles

Integrated Quality & Compliance System

TajMedico follows a robust Quality Management System (QMS) that includes:

  • GMP-compliant manufacturing
  • In-process quality checks
  • Batch traceability systems
  • Continuous training programs for technical teams
  • Risk-based quality assurance approach

Why TajMedico is a Trusted Global Partner

  • Strong regulatory intelligence and compliance system
  • Advanced manufacturing infrastructure
  • Expertise in multiple therapeutic segments
  • High-quality documentation and audit readiness
  • End-to-end support from development to commercialization

TajMedico continues to strengthen its global presence through regulatory excellence, manufacturing precision, and a commitment to delivering safe, effective, and affordable pharmaceutical solutions worldwide.