• Quality and Scientific Regulatory Services for Global Bio-/Pharmaceutical Industry

Welcome To 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 and Australia.

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 of skilled resources with core bio/ pharmaceutical industry experience having in-depth and updated understanding of GMP, Regulatory Affairs, Portfolio Strategy, Product Development and Project Management.

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

Integrity

Compliant to the highest ethical standards, our teams act with integrity and honesty and treat all client data with highest confidentiality. We do not outsource any services.

Passion

Our young and dynamic team of technical experts are passionate workers and accountable for results.

Excellence

We provide high quality, time bound services with high degree of success

Quality

Quality and compliance are at the core of every action of a Metina team member

Constant Improvement

We strive to improve our service constantly through learnings and feedback

Our Vision

To be a reliable regulatory and quality partner to the pharmaceutical and bio-pharmaceutical industry by providing comprehensive, knowledge driven & time bound services, with impeccable work ethics.

Our Main Services

GMP Excellence : EU/ PICS/ TGA/ Health Canada

GMP pre-audits, Compliance advise and bridging support, QMS documentation, Facility upgradation advise, mock up 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, Exigencies 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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EDQM Preparation & API CEP/ DMF 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 QP Audits, Vendor Qualifications & Due-Diligence

Third Party QP Audits, Vendor Qualifications & Due-DiligenceThird Party QP Audits, Vendor Qualifications & Due-Diligence
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Portfolio Partnerships

Portfolio Projects across the value chain, ranging from market specific portfolio strategy, defining regulatory pathway,  product development, commercial launch & local partnership
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Our Growth

In less than decade, Metina has grown exponentially in varied technical services starting from regulatory science to quality certifications for the manufacturing sites. Metina has advanced further by developing internal expertise for Biosimilar products development and trained pharmaceutical professionals in technical area.
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What Our Clients Say

Dr. Wagdy Mounir, General Manager, Marcyrl, Egypt

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.

Mr. Dilip Ghosh, Director, Gufic Group

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

Dr. Milind Joshi, President - Global Regulatory Management, Unique Pharmaceuticals Laboratories

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.

Ch’ng Kien Peng, Executive Director, Xepa-Soul Pattinson (Malaysia) Sdn Bhd

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.

Mr. Sanjay Pande, VP Quality, Zeiss Pharma

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. Mohan Jain, Director, Naprod Group

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. Deepak Keshav Vagale, Ex-DGM - Business Development, Global Pharmatech Pvt. Ltd.

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. Sameer Paigankar, Head- India Operations, Ingenus Pharmaceuticals USA

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. Viswajit Sahu, General Manager - Contract Manufacturing Services & In - Licensing, Wockhardt Limited

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. Vithal Dhamankar, Ex-Vice President - Emerging Markets, Wockhardt Limited

Metina PharmConsulting is a professional partner who understands regulatory scenarios in our operating countries. We have worked with them for the past one year during which they have done well with regards to the document reviews & on time delivery of product dossiers

Products Category

The Drug Products Category we operate with:

Generics

505 (b)(2) and 505(j) application with USFDA, Article 10 (1) submission in EU and national submission with independent agency.

Veterinary Medicines

EU GMP for veterinary medicines and product dossier filing with MAH in EU.

New Drugs

Super generics development support and approval.

Herbal

EU & Emerging markets submission and approval support.

Biosimilars

BLA submission via 351(k) pathway, Article 10(4) application with EU, BRICS-TM regulatory intelligence and submission.

Cosmetics

EU and Emerging markets regulatory intelligence and submission support.

Our Esteemed Clients