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current-menu-parent current_page_parent current_page_ancestor menu-item-has-children menu-item-6"><a href="https://www.almacgroup.com/pharmaceutical-drug-product-development/" class="c-navbar__dropdown">Pharmaceutical <span>Development</span><div class="c-menu__feature" data-url="6" new-data-url="/pharmaceutical-development/"> <figure> <img alt="Menu Feature Image" class="lazy-menu" data-src="https://www.almacgroup.com/pharmaceutical-drug-product-development/wp-content/uploads/sites/5/2023/09/Pharma-overview-main-nav-img.png"> </figure> <div class="text">Expert development & manufacturing solutions for all phases of clinical trials</div> </div></a> <ul class="sub-menu"> <li id="menu-item-68" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-home menu-item-68"><a href="https://www.almacgroup.com/pharmaceutical-drug-product-development/">Pharmaceutical Drug Product Development</a></li> <li id="menu-item-66" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-66"><a href="https://www.almacgroup.com/pharmaceutical-drug-product-development/our-facilities/">Our Pharmaceutical Development Facilities<div class="c-menu__feature" data-url="our-pharmaceutical-development-facilities" new-data-url="/our-facilities/"> <figure> <img alt="Menu Feature Image" class="lazy-menu" data-src="https://www.almacgroup.com/pharmaceutical-drug-product-development/wp-content/uploads/sites/5/2020/03/Our-Facilities-Featured-Image4.jpeg"> </figure> <div class="text">Providing a range of solid oral dose development and manufacturing services from 3 state-of-the-art facilities</div> </div></a></li> <li id="menu-item-70" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-70"><a href="https://www.almacgroup.com/pharmaceutical-drug-product-development/early-phase-pharmaceutical-drug-product-development/" class="c-navbar__dropdown">Pharmaceutical Development – Early Phase<div 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current_page_parent current_page_ancestor menu-item-has-children menu-item-62"><a href="https://www.almacgroup.com/pharmaceutical-drug-product-development/late-phase-pharmaceutical-drug-product-development/" aria-current="page" class="c-navbar__dropdown">Pharmaceutical Development – Late Phase<div class="c-menu__feature" data-url="pharmaceutical-development-late-phase" new-data-url="/pharmaceutical-development/late-phase-pharmaceutical-drug-product-development/"> <figure> <img alt="Menu Feature Image" class="lazy-menu" data-src="https://www.almacgroup.com/pharmaceutical-drug-product-development/wp-content/uploads/sites/5/2020/03/late-phase.jpeg"> </figure> <div class="text">Developing robust formulations and manufacturing processes suitable for late phase clinical trials.</div> </div></a> <ul class="sub-menu"> <li id="menu-item-71" class="menu-item menu-item-type-post_type menu-item-object-page current-menu-item page_item page-item-34 current_page_item menu-item-71"><a 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href="/flexible-gmp-manufacturing-capacity/">Flexible GMP manufacturing capacity<div class="c-menu__feature" data-url="flexible-gmp-manufacturing-capacity" new-data-url="/flexible-gmp-manufacturing-capacity/"> <figure> <img alt="Menu Feature Image" class="lazy-menu" data-src="https://www.almacgroup.com/pharmaceutical-drug-product-development/wp-content/uploads/sites/5/2020/03/flexible-gmp.jpeg"> </figure> <div class="text">Flexibility, cost and time are key criteria in evaluating options in a ‘build or buy’ decision for your technology.</div> </div></a></li> <li id="menu-item-1152" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-1152"><a href="https://www.almacgroup.com/analytical-solid-state/">Analytical Services</a></li> <li id="menu-item-853" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-853"><a href="https://www.almacgroup.com/commercial-services/pharma-services-virtual-tour-hub-access/">Almac Pharma Services Virtual Tour Hub</a></li> <li id="menu-item-59" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-59"><a href="https://www.almacgroup.com/pharmaceutical-drug-product-development/flexible-partnership-approach/">Flexible Partnership Approach<div class="c-menu__feature" data-url="59" new-data-url="https://www.almacgroup.com/pharmaceutical-development/customised-business-solutions/"> <figure> <img alt="Menu Feature Image" class="lazy-menu" data-src="https://www.almacgroup.com/pharmaceutical-drug-product-development/wp-content/uploads/sites/5/2020/03/Customised-Business-Solutions-Featured-Image2.png"> </figure> <div class="text">Providing flexible tailored solutions</div> </div></a></li> <li id="menu-item-58" class="nav-group-contact menu-item menu-item-type-post_type menu-item-object-page menu-item-58"><a href="https://www.almacgroup.com/pharmaceutical-drug-product-development/contact-us/">Contact Us</a></li> </ul> </li> </ul> </aside> </div> <div class="o-grid__item u-width-9/12 u-width-8/12@l u-width-full@s u-p-l4 u-p-l2@l u-p-l1@m u-p-b4 s-cms u-order-2@s">  <h2>Late Phase Pharmaceutical Drug Product Development</h2>  <h4 class="wp-block-heading" id="h-specialising-in-solid-oral-dosage-forms-almac-has-the-technical-experience-and-knowledge-to-develop-robust-formulations-and-manufacturing-processes-suitable-for-late-phase-clinical-trials-registration-and-ongoing-commercial-supply">Specialising in solid oral dosage forms, Almac has the technical experience and knowledge to develop robust formulations and manufacturing processes suitable for late phase clinical trials, registration and ongoing <a href="/commercial-services/commercial-drug-product-manufacture/">commercial supply</a>.</h4> <p>Our expertise covers the development of the following dosage forms:</p> <ul class="wp-block-list"> <li>Immediate and modified release capsules</li> <li>Immediate and modified release tablets</li> <li>Fixed dose combination products</li> <li>Powder/granule filled sachets</li> <li>Multi-particulates (bead/pellets into capsules)</li> <li>Minitablets</li> </ul> <p>Our manufacturing technologies and processing scales range from hundreds of grams for small-scale process investigation studies to hundreds of kilograms for phase III/IV, registration batches and commercial supply.</p> <p>We understand that the best way to ensure a smooth regulatory review process for an NDA or MAA is to clearly present a complete work package as defined through <a href="/pharmaceutical-development/quality-by-design/">Quality by Design</a>. By understanding the parameters that are critical to the quality of the product and the safety of the patient, we build quality into the product from the start, implementing effective control strategies.</p> <p>With comprehensive dedicated drug product <a href="/analytical-solid-state/">analytical testing</a> laboratories we provide timely, quality data to not only support your regulatory submission but to aid critical business decisions regarding packaging, shelf life and supply chain to ensure your drug product reaches patients in optimum condition.</p> <div class=" u-m-t-auto "> <a class="c-btn c-btn-primary c-btn--red" href="/pharmaceutical-development/contact-us/">Contact Us</a> </div> <div style="height:24px" aria-hidden="true" class="wp-block-spacer"></div> <article class="o-grid o-grid--full"> <div class="o-grid__item u-width-full u-m-t6 u-m-t4@m u-m-b4"> <h2 class="u-normal u-a-center">Related Resources</h2> </div> <div class="u-flex u-flex-justify-center u-flex-wrap 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