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 executed in batches in 6 months. We also have the capacity to produce capsule and tablet study batches of up to 125000 units. We always concentrate on the viability of the end product. Our experience in pharma manufacturing means we look at innovative production processes and systems too.
We have a 100% record of smooth technology transfers, with 10 out of 10 biostudies passed first time. (Any more on this?). Our osmotic technology portfolio has already lead to six new products being developed. (Any more on this?) IQGen-X has filed more than 1000 patent applications and had some 100 granted. (More on this?). That’s efficient and purposeful. We believe in making excellence the standard.
IQGen-X has already been recognised as one of the Top 50 Innovative Healthcare Companies globally in 2019, and as Innovative Company of the Year. (Who by?). 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.
Very low staff turnover at IQGen-X guarantees our sponsors on-going relationships, efficient thought, and purposeful work without repeats. Our partners are a close-knit group, having worked together for over 15 years. We enjoy the same mindset – which does not preclude rigorous debate.
Many of our 42 associates have worked with us through their PhD studies (we nurture new thought) and are thoroughly versed in international standard of Quality Assurance, data evaluation, and data review.
We foster an environment of rigorous honesty. Analytical mistakes can be made, or data misinterpreted. The importance lies in revealing and correcting. That’s efficient, meticulous, and purposeful.
Very low staff turnover at IQGen-X guarantees our sponsors on-going relationships, efficient thought, and purposeful work without repeats. Our partners are a close-knit group, having worked together for over 15 years. We enjoy the same mindset – which does not preclude rigorous debate.
Many of our 42 associates have worked with us through their PhD studies (we nurture new thought) and are thoroughly versed in international standard of Quality Assurance, data evaluation, and data review.
We foster an environment of rigorous honesty. Analytical mistakes can be made, or data misinterpreted. The importance lies in revealing and correcting. That’s efficient, meticulous, and purposeful.
Chairman & CEO, M Pharm, PhD (Tech),
AMLP, University of Oxford
Chief Analytical & Regulatory Officer
M Pharm, PhD
Chief US Operations
B Pharm, MS (US), PhD (US)
Executive Director and API Strategist
M Sc, PhD, Post Doc (US)
Defining New Prior Knowledge
RLD Characterization and identifying Critical Quality Attributes (CQA) Identification of Critical Material Attributes
(CMA) & Critical Process Parameters (CPP)
Outcome:
Defining the Qualitative Target Product Profile (QTPP)
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
Outcome:
Prototype Development finalization Defined scale-up and validation strategy
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
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
Outcome:
Prototype Development finalization Defined scale-up and validation strategy
