Achieve CMC Success with DLRC’s Expert Regulatory Consultants

The CMC or ‘Quality’ sections of regulatory submissions describe the ‘chemistry, manufacturing and controls’ of a medicinal product. They form one of the three critical elements that are essential to make a successful regulatory submission, i.e. Quality, Safety and Efficacy. These three components are highlighted by regulatory agencies worldwide as the areas where pharmaceutical companies need to satisfy them with information on their product(s). DLRC has a dedicated team of six senior and principal CMC regulatory consultants. They are complemented by several other regulatory consultants who also have a strong working knowledge of quality aspects.

Read on to discover just some of the areas DLRC CMC regulatory team can help you in the development of your pharmaceutical products. We have experience of many product types covering the range of small molecules, biologics and advanced therapy medicinal products (ATMPs).

How DLRC Can Support Your CMC Development

CMC Development Strategy

Engaging with our clients early in development is important as it enables our CMC experts to help with key decisions relating to formulation, manufacturing, analytical and stability testing. This enables us to prepare a strong strategy which will efficiently meet the requirements of regulatory agencies and support the ongoing development with the client’s product. Moving forward in development, we help our clients to devise formulations and manufacturing processes which are commercially acceptable and also representative of those used in clinical trials is a critical element of the quality development and will maximise the likelihood of success.

Regulatory CMC Writing

All DLRC CMC experts are proficient technical writers who can help clients create robust submissions. Our bread and butter is writing Investigational medicinal product dossiers (IMPDs) and Module 3 sections. We can either write the full Module 3 based on the research reports supplied by our clients or we can simply review Module 3 sections that the clients themselves have authored. We can also craft responses to difficult regulatory questions across all phases, interacting with the agency assessors if required. Producing briefing books for scientific advice meetings with clear, succinct CMC questions together with strong applicant’s positions is a task that we all regularly contribute to.

Additionally, we have CMC experts who are suitably qualified to act as the formal Quality Expert on MAA submissions, thus being able to write the module 2 Quality Overall Summary.

Risk and Technical Assessments

The DLRC team commonly face the challenge of assisting clients in understanding their readiness for a specific type of submission. We employ GAP analysis to help clients identify where they need to focus to achieve success. We possess high proficiency in conducting technical assessments for all aspects of CMC development. In ongoing projects, we regularly utilise risk analysis as a project management tool to identify potential pitfalls and prioritise them based on their potential impact and likelihood of occurrence. Consequently, we can effectively mitigate major stumbling blocks for our clients.

Various Product Types

DLRC CMC experts have worked with many clients on small molecules (both novel and established), herbal products, biologics and ATMPs. DLRC has worked on a wide range of dosage forms at various times including topical products, transdermal patches, sterile products, soft gel capsules, adhesive films, oral liquids and tablets. We have specific expertise in sterilisation processes and Inhaled products including DPIs, pMDIs, nebules and electronic nicotine delivery systems (ENDS). Approximately half of DLRC’s current client base is developing biological products hence our CMC experts have a great deal of experience in this field and we are supporting an increasing number of ATMPs including cell therapy and gene therapy such as mRNA in Lipid Nanoparticles, AAV vector, CAR T-cell and autologous somatic cell therapy.

In addition, DLRC is actively supports with developing drug-device combinations (DDCs). We benefit from a close collaboration with DLRC’s MedTech experts.

Post-Approval Change Management

The final area of focus is on how we help clients with life-cycle management of their products. There are a multitude of potential changes which we deal with shortly after licensing.  In some cases, these are known prior to approval, and regulatory authorities mandate them as post-authorisation measures. Or, the company plans for them as post-approval variations accordingly. For biological products the DLRC team can support in developing comparability protocols. These support the client in evaluating the risk of product differences, and post approval change management protocols (PACMP). Ultimately helping with effective planning and execution of complex changes.

Just some of the variations that we help our clients to plan for and manage include:

• Manufacturing site changes
• Manufacturing scale changes
• Reformulations
• API supply
• Excipient supplier changes
• Specification and analytical method changes
• Shelf-life extensions

These can often be grouped together as often one change leads to a succession of other changes. We have several clients where we manage these changes on their behalf. This ensures their approved pharmaceutical products have a robust supply chain.

Summary

The areas of support highlighted above cover just some of the many capabilities of the DLRC CMC regulatory team. In addition to the CMC Subject Matter Expert (SME) roles, our team can act as project leads and project managers for our clients’ submissions. Cross-functional interaction with our clinical and non-clinical SMEs and DLRC’s regulatory operations team provides a complete suite of services for our clients. To find out how DLRC can overcome your regulatory challenges, contact us at hello@dlrcgroup.com.