Your Partner for Global Regulatory, GMP Services & Third-Party Audits.
Your Partner for Global Regulatory, GMP Services & Third-party audits.
Metina Pharmaceuticals & Metina Australia :

Product Licensing and Supply

Metina Pharmaceuticals Pvt. Ltd.

Metina Pharmaceuticals Private Limited (MPPL) was established in 2020 as a sister concern of Metina Pharm Consulting, with its headquarters located in Navi Mumbai, India. The company was founded with a clear vision to expand Metina’s footprint from consulting to full-fledged pharmaceutical development and international export.

As a dedicated pharmaceutical firm, we are equipped with advanced pharmaceutical development facilities that support the development, scale-up, and commercialization of pharmaceutical formulations. Our capabilities span a wide range of dosage forms across multiple therapeutic categories, allowing us to meet the evolving needs of global healthcare systems.

In our role as a global pharmaceutical supplier, we work closely with manufacturing facilities that are approved by leading international regulatory authorities, including EU-GMP, TGA, PIC/S, and USFDA. This ensures that every product we supply meets the highest standards of quality, safety, and regulatory compliance.

Metina Pharmaceuticals specializes in offering high-quality pharmaceutical products for international markets, with a particular focus on Europe, UK, Australia and   Emerging markets. With a strong emphasis on regulatory compliance, innovation, and quality assurance, we have rapidly established ourselves as a reliable pharma exporter committed to global standards.

Backed by the technical expertise and regulatory know-how of Metina Pharm Consulting, we continue to forge partnerships worldwide and strive to be a trusted partner in advancing global health through access to safe, effective, and affordable medicines.

The entity provides end-to-end support for

End-to-end pharmaceutical product development through its network of EU GMP-certified manufacturing facilities. We support pharmaceutical companies in developing high-quality, regulatory-compliant products for regulated and emerging markets, from concept through commercialisation.

Our product development capabilities include

  • Formulation Development: Development and optimization of pharmaceutical formulations across various dosage forms, ensuring quality, efficacy, and manufacturability
  • Analytical & Stability Studies: Analytical method development, method validation, stability studies, and compatibility studies in accordance with international regulatory guidelines
  • Process Development & Technology Transfer: Process optimization, scale-up, process validation, and seamless technology transfer for commercial manufacturing
  • Regulatory Documentation: Preparation of CMC documentation, CTD dossiers, development reports, and technical documents to support global product registrations
  • Commercial Manufacturing: Manufacturing through qualified EU GMP-certified facilities, ensuring consistent product quality, regulatory compliance, and reliable global supply

Comprehensive regulatory support to ensure pharmaceutical products are developed and registered in compliance with international regulatory standards.

Our regulatory experts manage the complete dossier preparation and submission process, including

  • Development of products in accordance with global regulatory requirements
  • Preparation of high-quality CTD and eCTD dossiers
  • Regulatory gap analysis and documentation review
  • Dossier submission and lifecycle management
  • Liaison with national and international regulatory authorities
  • Support for obtaining and maintaining Marketing Authorization (MA)

With extensive regulatory expertise and a commitment to compliance, Metina streamlines the approval process, enabling faster market access while ensuring adherence to country-specific regulatory requirements.

  • Market Access & Export Strategy: Focus on regulated and emerging markets with market-specific regulatory and commercial strategy
  • Business Development: Identification of licensing, distribution, and strategic partnership opportunities to expand product portfolios globally
  • Partner Identification: End-to-end collaborations with qualified manufacturers, distributors, marketing partners, and local representatives across international markets
  • Commercialization: Market expansion via tailored product launch planning and smooth supply chain operations, ensuring successful product registration and market supply

Metina Australia Pty. Ltd.

Metina Australia Pty. Ltd. (MAPL) was established in 2019 as a wholly owned subsidiary of Metina Pharmaceuticals Private Limited, with the objective of strengthening our presence in regulated markets and facilitating operations in Australia.

As a local Marketing Authorization Holder, MAPL plays a critical role in bridging the gap between our international manufacturing partners and regional marketing partners, regulatory authorities, healthcare providers and distribution channels. Products registered by MAPL, whether for its partners or directly under its own IP, meet regulatory, safety and operational standards, while accelerating access to high-quality, affordable medicines for patients in Australia and neighbouring markets.

Metina Australia Pty Ltd.
Level 11, 139 Macquarie St, Sydney, NSW 2000, Australia.

Email
info@metinapharma.com

The entity has the following end-to-end capabilities

  • Strategic Regulatory Advice based on TGA’s input
  • Due diligence of the technical dossier to verify suitability for submission and approval with TGA
  • Writing of Module 1 as per TGA’s expectation, review of Module 2, 3, 4 and 5
  • PPF writing & submission to Health Authority
  • Support on Query response till approval
  • TGA GMP compliance verification for API and finished product site
  • MAH services along with associated Australia PV services
  • Adverse event (AE) collection, assessment, and reporting
  • Safety monitoring and signal detection activities
  • Risk management planning and implementation
  • Periodic safety reporting and regulatory compliance support
  • Product quality complaint management and reconciliation with safety data
  • Pharmacovigilance system maintenance, documentation, and inspection readiness
  • Coordination with local regulatory authorities and stakeholders on pharmacovigilance matters
  • Identification and evaluation of licensing and commercialisation opportunities
  • Negotiation and coordination of licensing, supply, and distribution agreements
  • Support for product portfolio expansion through in-licensing and out-licensing opportunities
  • Commercial and regulatory support for technology transfer and product launches
  • Supply chain operations to ensure uninterrupted product availability and market continuity
  • Ongoing partnership management to support long-term commercial success and lifecycle management

For pharmacovigilance-related queries, to report an adverse drug reaction, or to submit a product quality complaint, please contact us at:

info@metinapharma.com

Metina Pharmaceuticals Pvt. Ltd.
904, 9th Floor, Goodwill Infinity, Plot No E/3A, Sector 12, Kharghar, Tal- Panvel (Raigad), Maharashtra, India, 410210.

Metina Australia Pty Ltd.
Level 11, 139 Macquarie St, Sydney, NSW 2000, Australia.

Tablet

Capsule

Soft Gels

Lyophilized Injectable

Powder Injectables

Topicals