Taj Pharma has established itself as a regulatory-compliant, globally recognized pharmaceutical company. Its Regulatory Affairs (RA) division is instrumental in ensuring that the company’s products meet all international and domestic regulatory standards. The core responsibilities of this division revolve around regulatory intelligence, submission, and compliance across regulated and semi-regulated markets.

Key Functions of the Regulatory Affairs Department:

  1. Global Regulatory Compliance:
    • Well-versed in the regulatory frameworks of USFDA, EU EMA, MHRA (UK), TGA (Australia), WHO-GMP, ANVISA (Brazil), MCC (South Africa), and other global authorities.
    • Continuous monitoring of changing regulations across different countries and updating internal systems accordingly.
  2. Dossier Preparation & Submission:
    • CTD, eCTD, ACTD and country-specific dossier compilation.
    • Expertise in handling both new registrations and variation submissions for existing products.
    • Formats include Module 1 to Module 5, with meticulous attention to quality, safety, and efficacy data.
  3. Regulatory Strategy & Product Registration:
    • Strategic planning for regulatory submissions to reduce time-to-market.
    • Proactive interaction with health authorities to ensure fast-track approvals.
    • Product Lifecycle Management (PLM) to manage changes post-approval effectively.
  4. Labeling & Artwork Compliance:
    • Development and review of SmPCs, PILs, labels, and cartons to ensure compliance with local regulations.
    • Multilingual packaging capabilities with region-specific customization.
  5. Regulatory Audits & Inspections Support:
    • Documentation readiness for WHO, PIC/S, EU-GMP, and USFDA audits.
    • Timely responses to regulatory queries, deficiencies (observations), and CAPA implementation.
  6. Electronic Submissions:
    • Fully equipped infrastructure for eCTD/NeeS submissions, ensuring faster processing with authorities.
    • Use of advanced document management systems and regulatory publishing software.
  7. Liaison with International Clients & Health Authorities:
    • Seamless communication and support for clients seeking registration in MENA, CIS, Latin America, ASEAN, and African countries.
    • Experience in export registration documentation, LOAs, COPPs, FSCs, DMFs, MSDS, etc.

Pharma OSD & External Preparation Plant at Taj Pharmaceuticals

Taj Pharma’s Oral Solid Dosage (OSD) and External Preparation Manufacturing Facilities are state-of-the-art units adhering to stringent quality and safety standards. These plants are WHO-GMP certified and geared for domestic and international supply.

Oral Solid Dosage (OSD) Facility:

This plant caters to a wide range of oral solid formulations, including:

  • Tablets (plain, coated, chewable, dispersible)
  • Capsules (hard gelatin, softgel)
  • Pellets and Granules (sachets, blister packs, bulk)
Facility Highlights:
  1. GMP Compliant Infrastructure:
    • Dedicated clean zones, air handling units (AHUs), HEPA filters.
    • Segregated areas for granulation, compression, coating, encapsulation, and packing.
  2. Production Capabilities:
    • Batch sizes ranging from pilot to commercial scale.
    • Flexibility for generic, branded, and export contract manufacturing.
  3. Quality Control & Quality Assurance:
    • In-house QC lab equipped with HPLC, UV, FTIR, dissolution testers, etc.
    • Stability studies as per ICH guidelines (zones I to IV).
    • Validated processes and documentation: BMRs, BPRs, SOPs, etc.
  4. Packaging:
    • Blister, Alu-Alu, strip, bottle, and bulk packing available.
    • Track and trace systems integrated where required.

External Preparations Plant:

This division handles the manufacturing of topical and dermatological formulations, such as:

  • Ointments
  • Creams
  • Gels
  • Lotions
  • Medicated shampoos
  • External liquids (antiseptics, liniments, etc.)
Facility Features:
  1. Dedicated Topical Facility:
    • Separate processing zones for emulsions, semi-solids, and liquids.
    • Specialized equipment: planetary mixers, homogenizers, filling and sealing machines.
  2. Microbial Control:
    • Controlled environment ensuring minimal bioburden.
    • Routine environmental monitoring and microbial limit testing.
  3. Formulation Versatility:
    • Capability to manufacture Rx, OTC, and cosmeceutical external applications.
    • Support for customized pack sizes and private labeling.

Why Taj Pharma Stands Out

  • Global Regulatory Expertise: With a seasoned RA team, Taj Pharma ensures complete, timely, and compliant submissions across global markets.
  • Manufacturing Excellence: Facilities designed as per EU GMP / WHO GMP / PIC/S standards.
  • Client-Centric Approach: Offering full support — from product selection to dossier filing and post-approval maintenance.
  • Therapeutic Coverage: Extensive portfolio across antibiotics, cardiovascular, oncology, neurology, dermatology, and more.