Efficient.
Meticulous. Purposeful.

IQGenX, established in 2017 by pharma industry veterans, is a leading Contract Research Organization (CRO) based in Mumbai. With our guiding principles of Innovation, Quality and Excellence; we have been able to successfully complete technology transfer for over 15 products with a “First-Time-Right” approach. Our Clients/Partners filed more than 6 ANDAs for the US market as of now with about 6 more in advanced stage of submission. Our Clients/Partners trust our capabilities and expertise to develop, scale-up and commercialize niche and complex oral and injectable products

Contract Research must be efficient.

A well-planned strategy with the end-goal in mind, with a flawless, time-bound and cost-effective execution being the outcome. We endeavor to deliver these benefits to the Clients/Partners.

Contract Research must be meticulous. 

Planned with sound scientific rationale, we strive to provide robust technology meeting QbD framework. Our strong commitment to data integrity guarantees a high-quality dossier which provides speed to market advantage to our Clients/Partners.

Contract Research must be purposeful. 

Product technology and processes need to move from the laboratory to the production line in a seamless and predictable manner. Technology transfer is not just about profits without waste –it is also about efforts that bring affordable medication to the world.

Count on us to do it right.

We’re motivated and committed to what we can achieve together.

Quality should never be left to chance.

We make excellence the standard.

Efficient speed to market.

Our purposeful approach and meticulous documentation set a new benchmark for a Paragraph IV ANDA filing in the United States, going from concept to filing in just 18 months.

Then, our new injectable bags were developed and batches executed in 6 months.

We also have the capacity to produce capsule and tablet study batches of up to 125,000 units in-house.

We always concentrate on the viability of the end product. Our experience in pharma manufacturing means we look at appropriate production processes and systems too.

Purposeful technology transfer.

We have a 100% record of smooth technology transfers, with 10 out of 10 biostudies passed first time.

Our osmotic technology portfolio has already led to six new products being developed.

That’s efficient and purposeful. We believe in making excellence the standard.

Recognitions of excellence.

IQGenX has already been recognised as one of the Top 50 Innovative Healthcare Companies globally in 2019 and 2021.

We’re immensely proud of our new partnership with ACG; it increases the scope of what we can achieve for our customers, and for healthcare the world over. ACG is a global leader in the pharma-supply industry; the world’s largest integrated supplier of hard-shell capsules, film and foil barrier solutions, track and trace systems, and process, packing and inspection equipment.

Count on us to do it right

Our entire leadership team have backgrounds in pharmaceutical development; each has a strong professional record of innovation and entrepreneurship.

We nurture talent which, in turn, fosters employees with equal commitment to our mission. Many of our 42 associates performed significant portions of their PhD research projects with us and were subsequently recruited as staff scientists.

Cross-training in regulatory and quality assurance ensures their career at IQGenX produces well-rounded pharma development professionals.   

Our advisors, industry partners, financiers and community have remained with us from inception, demonstrating their commitment and support to our ideal of building the finest CRO in India.

Our team

Dr. Mandar M Kodgule

Chairman & CEO

M Pharm, PhD (Tech),
AMLP, University of Oxford

Dr. Yogita Kodgule

Chief Analytical & Regulatory Officer

M Pharm, PhD

Dr Yatendra Kumar

Executive Director and API Strategist

M Sc, PhD, Post Doc (US)

Dr Madhu Hariharan

Board Member/Strategic Advisor

B Pharm, PhD (US)

Karan Singh

Bachelors degree from Michigan University

MBA from Harvard Business School

Dr Parizad Elchidana

Ph.D

Quality is never
left to chance.

Review, review, review is our mantra. Every stage must be built on solid evidence that stands up to vigorous questioning. Quality cannot be left to chance; excellence must be the standard.

DEFINE

  • RLD Characterization and identifying Critical Quality Attributes (CQA)
  • Identification of Critical Material Attributes (CMA) and Critical
Outcome: Defining the Qualitative Target Product Profile (QTPP)

DESIGN AND CONTROL

  • Design of Experiments (DoE)
  • Process Analytical Technology (PAT) implementation
  • Verification of CQAs, CMAs and CPPs
  • Risk Assessment
  • Preliminary stability assessment
  • Analytical method verification and partial validation
  • Defined scale-up and validation strategy
  • Alternate strategies with risk mitigation plan
Outcome: Prototype Development finalization

VALIDATION

  • Product and process scale-up
  • Risk Mitigation Strategy
  • Validation of process with technology transfer
  • Analytical methods validation with technology transfer
  • Registration batches and stability evaluation
  • Assessment of Bioequivalence
Outcome:  Filing of Dossier/ANDA

CONTROL AND MONITOR

  • Query response management
  • Commercial risk assessment and mitigation plan
  • Approval and launch plan
  • Continuous improvement and monitoring plan
  • Alternate sourcing strategy
Outcome:  Commercial launch Lifecycle Management

Careers

IQGenX provides a great environment for the development and growth of its associates. At IQGenX, we welcome job applications from both freshers and experienced pharmaceutical professionals. We have job openings for the following functions:

  • Formulation Development,
  • Analytical Development,
  • Regulatory Affairs,
  • Quality Assurance.

IQGenX has signed MoUs with various reputed educational institutes such as Institute of Chemical Technology (ICT), Bombay College of Pharmacy (BCP), Poona College of Pharmacy (PCP), Bhanuben Nanavati College of Pharmacy (BNCP) and VES College of Pharmacy. We welcome enquiries for collaborative research opportunities with reputed institutions under following areas.

  • Research guidance and infrastructure for Masters and PhD programs
  • Training and development of undergraduate students
  • Joint research projects as a part of Industry-Academia interaction

Making Excellence the Standard

ANDA/Dossier development

  • Product identification, development, scale-up and technology transfer.
  • Development and regulatory strategy for 505b2 and complex/niche generics.
  • Trouble-shooting and solutions from formulation, analytical and regulatory perspective.
  • End-to-end CDMO support for ANDA/dossier filing, approval and commercialization.
  • Management of post-approval changes to optimize cost and comply with regulatory requirements.

Stand-alone services

  • Formulation Development for solid orals and injectables
  • Scale-up for solid orals
  • Analytical Method Development and Validation
  • Stability studies under ICH guidelines including Zone IV
  • Dossier/ ANDA compilation
  • Regulatory strategy and correspondence
  • API Portfolio Strategy
  • Clinical supplies for oral solids
  • Product Portfolio and IP Strategies

Oral Solids and Liquids

  • Quick release
  • Conventional release
  • Modified/delayed/extended release
  • Oral solutions and suspensions

Injectables

  • Injectable solutions/suspension
  • Long-acting injections

Opthalmics

  • Solutions & suspensions

We welcome your enquiries, comments, & business proposals.

We are keen to play a part in realizing your product ideas – dedicated staff are ready to answer your CRO service enquiries, general comments or specific business proposals. Call or message us today. Let us prove why customers always count on us to do it right.

Dr Mandar M Kodgule
Chairman & CEO

M Pharm, PhD (Tech), AMLP, University of Oxford

CAREER EXPERIENCE of over 20 Years with leading Pharmaceutical companies and Startups such as Wockhardt, Glenmark, Ranbaxy in Leadership role working closely with Senior Leadership team in areas of Chemical research, Formulation development, Intellectual Property, Corporate Strategy, Alliance Management, Merger & Acquisition, Business Development and Budget planning.

RESPONSIBLE in IQGen-X for Mission, Policy and Planning; Management & Administration; Governance & Legal Compliance; Project Management, Intellectual Property, Investor and Community Relations

Dr. Yogita Kodgule, Chief Analytical & Regulatory Officer

M Pharm, PhD

CAREER EXPERIENCE of 20 years with Sun Pharma, Ranbaxy and Wockhardt in areas of Analytical Research, Regulatory Affairs, Compliance and Auditing

RESPONSIBLE in IQGen-X for Analytical & Regulatory Affairs – Filing and approval Compliance and third party audits and due diligence

Dr Yatendra Kumar, Executive Director and API Strategist

M Sc, PhD, Post Doc (US)

CAREER EXPERIENCE of 33 years with AstraZeneca, Ranbaxy, Wockhardt in leadership roles in areas of R&D Management and delivery, API Research & Manufacturing, Analytical Research, Regulatory Affairs, BE and Clinical research.

RESPONSIBLE in IQGen-X to create execution excellence; API planning, development and commercialization

Dr Madhu Hariharan,
Board Member/Strategic Advisor

B Pharm, PhD (US)

CAREER EXPERIENCE of 25 years with Pfizer, Abbott, Aquestive and Banner in areas of complex product development, life cycle management, abuse deterrent narcotic products, Regulatory Affairs, Sales & Distribution and Business Development. Entrepreneurial Skills to set up new businesses and ventures (SolvEkta, Mucodel, Nova Thin Film etc

RESPONSIBLE in IQGen-X as Technical and Strategic Advisor.

Mr. Karan Singh
Bachelors degree from Michigan University

MBA from Harvard Business School

Absolutely committed to building a healthy world, Karan Singh, Managing Director, ACG envisages ACG as a future ready partner to the pharma industry, helping them produce better quality and safer medicines. He is passionate about converting ideas into growth opportunities and takes a keen interest in entrepreneurial visions that solve real world challenges in healthcare and wellness. From integrating new -age technology, product engineering and acquiring core expertise in the sector, he has spearheaded ACG’s growth into an innovative solutions provider.

Under his tutelage, ACG has grown from its modest roots in India into a transnational company, serving over several global customers across 100 countries with its own facilities and teams spread across Asia, Europe, Americas and Australia.

Dr Parizad Elchidana

Ph.D

Dr Parizad Elchidana is Ph.D. in Pharmaceutical Sciences, and holds additional qualifications in Quality Management Systems, Business Management and Computer Science. She has over three decades of experience in the pharma industry. She started her career with R&D and clinical research and has handled green field projects as Managing Director/CEO for foreign investors in India and managed a start up in UAE as CTO.

She is currently associated with ACG as Principal Technical Consultant – Pharma and has been recently appointed as a director on board of IQGEN – X. She has several patents and research publications to her credit. Dr Elchidana is an invited speaker at various national and international seminars and symposia. She is an honorary visiting faculty, Ph.D. guide, examiner for M. Pharm and Ph.D. and is on the technical advisory board of SciTech and various pharmacy colleges in India, and UAE. She is the president of Controlled Release Society, Indian Chapter and co-chair of American Association of Pharmaceutical Scientists Western India Chapter, Mumbai Discussion Group. She is also the president of Bombay College of Pharmacy Alumni Association.

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