Your Partner for Global Regulatory, GMP Services & Third-Party Audits.
Your Partner for Global Regulatory, GMP Services & Third-party audits.
GMP Excellence (Pharmaceuticals,
Biologicals & Veterinary Products): EU/ PICS/ TGA
Drug Product Regulatory: EU, UK, Australia,
US, Canada, WHO & Emerging Markets
Biosimilars & Vaccines
Regulatory Support
API: CEP/ASMF/DMF/EDQM
GMP Services
Third Party Vendor Audits,
EU QP Audits & Technical Due- Diligence
Product Development
& Technology Transfer
Product Licensing
& Supply

Metina PharmConsulting

ISO 9001: 2015 Certified for Quality Management Systems.

In the area of Good Manufacturing Practices (GMP) and Global Regulatory Affairs.

Established in 2012, Metina is an India based company with its headquarters in Mumbai and subsidiaries in Singapore, Malaysia, Australia and Europe.

Metina is a pharmaceutical and bio-pharmaceutical consultancy organization engaged in GMP consulting, Regulatory services for small molecules & biosimilars, Third Party QP Audits, Technical Due-Diligence projects & Portfolio Strategy. Our services span Regulated as well as Emerging Markets. Our technical team comprises skilled resources with core bio/ pharmaceutical industry experience having in-depth and updated understanding of GMP, Regulatory Affairs, Portfolio Strategy, Product Development and Technology Transfer.

We strive to be a reliable Regulatory, GMP, and Due-Diligence partner to the industry by offering comprehensive, knowledge driven, time bound and high-quality services.

Integrity

We act ethically, protect data, and never outsource any services.

Passion

Our young team works with energy, dedication, and strong accountability.

Excellence

We deliver timely services with consistency, precision, and success.

Quality

Quality and compliance guide every action, decision, and team effort.

Improvement

We learn, adapt, and grow through feedback, innovation, and experience.

Metina Subsidiaries

Services Offered

GMP Excellence (Pharmaceuticals, Biologicals & Veterinary Products): EU/ PICS/ TGA

GMP Pre-Audits, Compliance Advice and Bridging Support, QMS Documentation, Facility Upgradation Advice, Mock Inspection, QP Audit, EU GMP Inspection to Certification Hand Holding, Annual Report Submission

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Drug Product Regulatory - EU, UK, Australia, US, Canada, WHO & Emerging Markets

End-to-End Regulatory Services Covering Regulatory Strategy, Scientific Dossier Writing, Submission to Health Authority, Query Response, Pricing Approval, Marketing Authorization Approval & Product Life Cycle Management

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Biosimilars & Vaccines Regulatory Support

BLA Review, Scientific Writing and CBER Submission Under 351(k) Pathways with USFDA, Centralised Application Under Article 10(4) with EEA, Expert Intelligence for Biosimilar Licensing in BRICS-TM Markets

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API: CEP/ASMF/DMF/EDQM GMP Services

DMF/ASMF/CEP Scientific Writing, Submission with Agency, Support in Resolving Questions, Third Party API QP Audit, QP Audit Report, CAPA Preparation, QP Declaration, CEP Certification, EDQM GMP Support

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Third Party Vendor Audits, EU QP Audits & Technical Due-Diligence

Comprehensive Third Party QP Audits, Vendor Qualifications, Due-Diligence Services to Ensure Compliance, Quality Assurance, Risk Mitigation Across Your Supply Chain and Partner Network

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Product Development & Technology Transfer

Portfolio Projects Across the Value Chain, Ranging from Market Specific Portfolio Strategy, Defining Regulatory Pathway, Product Development and Successful Technology Transfer

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Product Licensing & Supply (Metina Pharmaceuticals Pvt. Ltd.)

Niche Product Portfolio Available for Licensing and Supply in EU, UK and ANZ

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Years of Experience
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Countries We Serve
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Regulatory Submissions
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EU GMP Projects Executed
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Our Clients

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What Our Clients Say

We sincerely appreciate the efforts Metina have put many times for Marcyrl group’s facilities. We appreciate the efficiency, gracious support, the level of detail and accountability Metina has demonstrated on each project. Metina supports us for identifying and implementing strategies to increase capability of Marcyrl group facilities to grand European certificate. Marcyrl Pharmaceuticals company, one of Marcyrl group has achieved phenomenal success as passing EMEA audit for Solid department in a short duration. Marcyrl group wish the recurrence of this success with facilities of Marcyrl within upcoming few years. Again, thank you so much for your support, we greatly appreciate the assistance you have provided us.

Dr. Wagdy Mounir

General Manager, Marcyrl, Egypt

Metina PharmConsulting has been instrumental in successfully executing EU GMP approval for Gufic Lifesciences Pvt Ltd by handling the project on end to end basis. The association with Metina team headed by Mrs. Hasumati Rahalkar has been nothing short of excellence. They have good understanding of the subject and can steer a given project successfully with a professional approach .They are communicative and responsive to client queries and requests. It has been great pleasure working with Metina team and would recommend them to anyone looking for services in this sector

Mr. Dilip Ghosh

Director, Gufic Group

We have worked with Metina for number of times for our various facilities. I appreciate their timely assistance rendered. We were happy with their service. We could obtain EU GMP Certificates for our facilities with their prompt services.

Dr. Milind Joshi

President – Global Regulatory Management, Unique Pharmaceuticals Laboratories

We have worked with Metina on our Melaka plant and we are happy to say that we found the team professional and knowledgeable with brilliant work ethics. Any company needs a good level of trust in a consultant with whom they are sharing their manufacturing and production related data. Metina’s data integrity is second to none and we never had any apprehensions about the entire team. Overall the project was well executed, in a timely and professional manner and we got EU GMP certified, which will undoubtedly be a good boost to our business in the international arena.

Ch’ng Kien Peng

Executive Director, Xepa-Soul Pattinson (Malaysia) Sdn Bhd

It was wonderful experience to work with you for more than a year. As a part of Zeiss team, we found you very much competent and aware of GMP and Inspection requirement. One of the good things observed in your team is that you have individual subject matter expert focusing in their area and supporting clients during preparation for audit. We are thankful for pre and post audit support till getting the GMP Certificate. Yours professionalism and client confidentiality is really admirable. In your guidance and support, we got EU GMP audit successful.

Mr. Sanjay Pande

VP Quality, Zeiss Pharma

We hired Metina to help us get EU accreditation for our Oncology Injectable, Oncology Oral Solids and General injectable facility. Metina has a wealth of knowledge in the field of GMP and regulatory practices & have a practical and results oriented approach. Metina was chosen because we needed someone who could work with our existing processes, and work along with the team. They were able to respond to the needs in a prompt manner. It is a very professionally managed group with its team members adhering to strict confidentiality at all times. There strategic input and direction was instrumental in obtaining EU-GMP certification.

Mr. Mohan Jain

Director, Naprod Group

Global Pharmatech Private Limited is associated with METINA PharmConsulting for EU & Emerging Markets Project. During our work, we have found METINA’s team very professional, goal-oriented with good trouble shooting skills and impeccable work ethics. Metina is working as a part of our team and offers dedicated support for our company’s business growth & aspirations.

Mr. Deepak Keshav Vagale

Ex-DGM – Business Development, Global Pharmatech Pvt. Ltd.

We are working with METINA PharmConsulting for our US-ANDA projects. During our association, we have found that METINA has a very high level of regulatory expertise in terms of ANDA drafting and CMC /BE data review. Their communication with different operational teams is appreciable. We have found them to be very trustworthy transparent and dependable. We wish them all the best!

Mr. Mohan JainMr. Sameer Paigankar

Head- India Operations, Ingenus Pharmaceuticals USA

Metina PharmConsulting is managed by well experienced professionals from the industry who monitor and understand the regulatory scenarios in our operating countries. They are very focused on their assignment of deliveries. We have being working with them for the past one year during which they have done well in review of product dossiers and on time delivery of dossiers.

Mr. Viswajit Sahu

General Manager – Contract Manufacturing Services & In – Licensing, Wockhardt Limited