Your Partner for Global Regulatory, GMP Services & Third-Party Audits.
Your Partner for Global Regulatory, GMP Services & Third-party audits.
ISO 9001 : 2015 Certified for Quality Management Systems
In the area of Good Manufacturing Practices (GMP) and Global Regulatory Affairs.
Established in 2012, Metina PharmConsulting is an Indian company headquartered in Mumbai, with subsidiaries in Singapore, Australia, Malaysia and Europe. We are a pharmaceutical and bio-pharmaceutical consultancy organization engaged in GMP Consulting, Regulatory services for small molecules & biosimilars, Vendor Qualification and Third-Party audits, Technical Due-Diligence projects & Portfolio Strategy. Our services span Regulated as well as Emerging Markets.
Metina provides end to end regulatory services starting from due diligence, gap analysis of the dossier, product development guidance, regulatory strategy, scientific writing of dossier, submission to health authority, query response and approval. Our services cover APIs and Formulations for USA, EU, WHO PQP and Emerging Markets as well. We have obtained multiple submissions and approvals for ANDAs, DCPs, National Submissions in EU, WHO PQP, MCC-South Africa and TPD-Canada. Metina has filed 505(j), 505(b)(1) and 505(b)(2) application with USFDA and received approvals while performing multiple controlled correspondence with USFDA.
In the last few years, Metina has built expertise in the area of Biosimilars and Vaccines and we are now equipped to take on end-to-end regulatory support for this category of products across BRICS-TM (including India) countries and regulated markets.
In the domain of Quality and Compliance, Metina has established a strong track record of success with EU GMP & PIC/S services. We are also fully equipped to carry out inspections from regulatory bodies including WHO PQP, TGA, TPD, Health Canada, EDQM and others.
With our strong expertise on regulatory and compliance, we are well equipped to handle all kind of Technical Due-diligence Projects and provide unbiased opinions to Financial Institutions and companies for investment projects in the pharmaceutical industry.
We also support companies in Developing Pharmaceutical Products across dosage forms at an accredited formulation development laboratory, in line with EU / US reference product. Post development, the product technology can be transferred to the suggested manufacturing location.
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.
At Metina, the team is young, dynamic and high performing, practicing the art of continuous learning! We have a team of in-house technical experts with strong industry experience in regulatory, quality & compliance, formulation development, technology transfer and portfolio strategy. The directors of the company, Dr. Hasumati Rahalkar, Dr. Shobhna Aanand, Mr. Amar Rahalkar and Mr. Rajeev Gangwar are Pharmaceutical Industry veterans, having held leadership roles across multi-national companies.
Experienced professional with over 30 years of work experience in the Pharmaceutical Industry in QA, QC, Regulatory Affairs and Product Development with core focus on handling regulatory affairs for US, EU and Emerging markets. She founded Metina PharmConsulting in 2012, focused on providing EU GMP & Global Regulatory services. As a Regulatory Affairs lead in multinationals & currently as an Entrepreneur running a successful consulting service, she has spearheaded regulatory strategy development & execution for both small molecule generics & biosimilars.
She gained strong expertise in defining Global Regulatory Strategies, Marketing Authorization Application submissions and approvals for New Drug Applications Branded generics & Biologics across Regulated & Emerging Markets. She has also established GMP consulting as a core area of strength for the company with over 50 successful EU GMP certifications.
She is the first Indian regulatory professional to be awarded with TOPRA Fellowship (The Organisation for Professionals in Regulatory Affairs, UK) and has done her PhD in Regulatory Science with focus on Biosimilars, from the University of Hertfordshire- UK. She holds additional qualifications of Regulatory Affairs Certification (EU & US), Certification in Patent Drafting & Procedure, along with Post Graduate Diploma in Management & International Trade.
With over 22 years of professional experience spanning Strategy, Portfolio Planning, Business Development (Licensing/ Acquisitions/ Divestitures) & New Market entry, Dr. Aanand combines strong domain knowledge with a sharp business acumen.
Having worked across multinationals such as Glenmark, Lupin & Pfizer, she has held leadership roles in the domain of business development, portfolio strategy & project management including General Manager for Emerging Markets at Glenmark, Head of Alliance Management at Lupin, Lead – BD & Director Marketing at Pfizer India.
Dr. Aanand has worked across regulated and emerging markets such as Europe, Latin America, Russia -CIS, Africa & Asia where she has launched successful brands, acquired & divested portfolio, scaled up businesses and led complex techno-commercial projects to fruition.
She joined Metina PharmConsulting in 2019 and has successfully scaled up and diversified the consulting business adding global clients while establishing a strong and dynamic internal team. At Metina, she leads Portfolio Strategy, Project Management & also works closely with Technical Team to meet core project objectives.
A seasoned businessperson with over two decades of entrepreneurial experience, Mr. Amar Rahalkar, co-founded the Falcon & Metina Group back in 2003. Over the past 22 years, Mr. Rahalkar, has spearheaded a remarkable transformation, evolving a humble trading company into a diversified conglomerate with a global footprint. Today, The Falcon & Metina Group encompasses 12 companies across 4 distinct business verticals, with fully owned subsidiaries in Singapore, Malaysia, Australia and Hungary.
As a leader, Mr. Rahalkar is distinguished by his unwavering diligence, unrelenting determination, and clear focus on delivering exceptional results. His commitment to ethical thinking and practices has been a cornerstone of the group’s success, fostering a culture of integrity, transparency, and accountability across the organization. Through his leadership, Mr. Rahalkar has instilled a strong work ethic and a passion for excellence, driving the group towards its goals and aspirations.
As the Group’s Chief Financial Officer (CFO), Mr. Rahalkar plays a pivotal role in overseeing the financial management, compliance, and regulatory affairs of the entire group. With his expertise in financial planning, risk management, and governance, he ensures that the group’s financial operations are aligned with its strategic objectives, while maintaining the highest standards of transparency and accountability. Through his leadership, Mr. Rahalkar has established robust financial systems and processes, enabling the group to navigate complex financial landscapes and achieve its growth ambitions.
A seasoned businessperson with over two decades of entrepreneurial experience, Mr. Gangwar co-founded the Falcon & Metina Group back in 2003. Over the past 22 years, Mr. Gangwar has spearheaded a remarkable transformation, evolving a humble trading company into a diversified conglomerate with a global footprint. Today, The Falcon & Metina Group encompasses 12 companies across 4 distinct business verticals, with fully owned subsidiaries in Singapore, Malaysia, Australia and Hungary.
As a seasoned entrepreneur with a global outlook, Mr. Gangwar brings a unique blend of international experience and innovative thinking to the table. With a keen ability to navigate complex business landscapes and seize opportunities in diverse markets, he has developed a bold and forward-thinking approach to business, that is characterized by a willingness to challenge conventional wisdom and push boundaries.
As the Group’s Chief Executive Officer (CEO), Mr. Gangwar plays a pivotal role in shaping the strategic direction and decision-making processes across all business verticals. With a deep understanding of the group’s diverse operations and a keen eye for opportunity, he provides visionary leadership, guiding the development and implementation of strategies that drive growth, innovation, and excellence across the organization.
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