Metina Pharmconsulting provides regulatory affairs consultancy services to international drug substance and product manufacturers, specialising in quality assurance (QA), quality control (QC) and product development.
The company’s services comprise Drug Product Development with contract research and manufacturing service (CRAMS) identification and Technology Transfer, Regulatory Services for small molecules and biosimilars, EU good manufacturing practice (GMP) Services for manufacturing facilities, Good Practice (GxP) Inspection Services, and Regulatory Training.
Metina has an in-house team of project development experts, inspectorates and regulatory personnel at its headquarters in Navi Mumbai, India.
Drug product development, contract research and manufacturing services (CRAMS) identification and technology transfer
Metina supports pharmaceutical companies in developing required dosage forms at an accredited formulation development laboratory, in line with EU / US reference products.
Metina has played a key role in developing injectables, topicals and oral solid dosage forms for the US and EU markets. Post-development, the product technology is transferred to a suggested manufacturing location.
With the help of EU-accredited manufacturing sites, Metina helps clients identify a site for technology transfer following a comprehensive analysis to assess suitability. Metina also identifies and organises technology transfer to suitable contract manufacturing locations post-development.
Regulatory services for small molecules
Metina provides end-to-end regulatory services ranging from due diligence, gap analysis of dossiers and product development guidance to regulatory strategy, scientific writing, submissions to health authorities and query response and approval.
The services support formulation and active pharmaceutical ingredients (API) for submission to the US, EU, the World Health Organisation (WHO) Prequalification of Medicine Programme (PQP) and emerging markets.
Metina also obtains multiple submissions and approvals for abbreviated new drug applications (ANDA), decentralised procedures (DCP) and National Submissions in the EU.
In addition, Metina files 505(j), 505(b)(1) and 505(b)(2) applications with the US Food and Drug Administration (FDA), as well as manages portfolios for ANDAs and conducts multiple control correspondence with the US FDA.
Metina has multiple submissions and approvals for DCP in the EU, National Submissions in the EU, WHO PQPs, the Medicines Control Council (MCC) of South Africa and the Therapeutic Product Directorate (TPD) of Canada. Metina secures regulatory approvals for products in Asia, Africa, the Commonwealth of Independent States (CIS), Russia and Latin America markets.
Within the DCP application, the company organised receipt of the DCP slot booking, wrote modules one to five, converted the document into an electronic common technical document (eCTD) format, submitted the dossier online to reference member states (RMS) and concerned member states (CMS), and responded to queries and till product licences.
EU GMP inspection services
In association with the Hungarian authority, Metina schedules EU GMP inspections, including organising pre-audit inspections and slot arrangement, obtaining a terms and conditions (T&C) letter from the authority and preparing plants for EU GMP inspection. It also considers EU-specific expectation, provides support throughout the inspection and helps to prepare corrective and preventive actions (CAPA).
Metina also collates documents, including the inspection observation report and the EU GMP certificate, as well as the publication of the EU GMP certificate on the EudraGMP website. The company also helps to submit the CAPA.
So far, the company has supported more than 19 manufacturing locations to achieve EU GMP certificates, with another 20 plants currently scheduled for inspection. These sites are approved or under approval for various dosage forms such as oral solids (tablets and capsules) and soft gelatin capsules; oral liquids; dry syrups; topical treatments, creams and gels; lyophilised, dry powder and liquid injectables; hormonal injections; lozenges; metered-dose inhalers (MDI); sterile eye and ear drops; pre-filled syringes; oncology oral solid injectables; and biosimilars.
GxP inspection support
Metina provides comprehensive support for GMP and good laboratory practice (GLP) verification, analytical research and development, formulation and development, formulation and development (F&D), API and finished dosage forms (FDF) manufacturing, warehousing and clinical sites.
Biosimilar regulatory services
Metina is experienced with biosimilar development and submission to the European Medicines Agency (EMA), the US FDA’s Centre for Biologics Evaluation and Research (CBER), Canada’s TPD, Australia’s Therapeutic Goods Authority (TGA) and WHO. The company has explored the regulatory pathways under 351(k) submissions and centralised procedure (CP) with the UK team.
Metina is working with Brazil, Russia, India, China and South Africa (BRICS) agencies to develop regulatory models for speedy biosimilar approval in the emerging markets and is associated with the EMA, Turkey and other emerging market agencies to develop biosimilar pathways and guidelines.
Regulatory training service
Metina provides specialist regulatory guidance training as both in-house and on-site courses.
The training covers more than 100 regulatory and quality topics such as research and development (R&D), QA, QC, production and regulatory affairs, as well as WHO PQP and EU regulatory submissions such as GMP. So far, the regulatory training programmes have been conducted on topics such as WHO PQP, EU GMP and regulatory submissions in the EU.