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Regulatory CMC

The knowledge and experience to smooth the path through Regulatory approvals

Navigating the regulatory approval processes is an essential step on the Drug Development journey, getting this right leads to the fastest and smoothest development. Through every stage one needs to provide an appropriate submission that shows that the quality of the product is suitably controlled and so will secure approval but also provide flexibility needed for a robust supply of your Investigational Medicinal Product.

The team at Seda have extensive experience of authoring and review of the CMC modules of regulatory submissions at all stages of development and across all the main global markets. We also have specialist Regulatory CMC consultants (including an ex-MHRA Assessor) available for deeper reviews and development of the overall regulatory strategy.

We apply a phase appropriate approach. In the early phases of development, we can help you to design the experimental program to deliver the data required for your First in Human application and author the application to secure approval balancing the need to demonstrate suitable quality without overly constraining the manufacturing process in these early days of development when limited data on the product exists.

As you proceed through the clinical phases, we can help to ensure that your CMC data package develops to meet the growing expectations of the regulatory authorities with regard to data and understanding of product quality. We pragmatically apply Quality by Design approaches and specifically the development of a holistic Control Strategy that will become the cornerstone of your Marketing Application.

For many products the dissolution test will be an important element of the control strategy and justification of this test and ideally the development of clinically relevant dissolution specification (CRDS) is a topic of great regulatory importance. Seda experts have extensive experience in the development and justification of dissolution test and specifications and are recognised world leaders in the field of CRDS.

Seda can also guide you through your interactions with Regulatory Agencies including development of Questions and Briefing materials, team preparation, and representation of Clients at face to face interactions.

Why choose Seda?

The Seda team have taken more than 15 products right through the development process to commercialisation and can guide you through every step of the way. The leadership team have long been recognised as influencers in evolution and modernisation of global regulatory guidelines, in particular in the development of the Quality by Design initiative and the establishment of clinically relevant dissolution methods. For example, Drs Stott and Dickinson have been active members of numerous Industry : Agency initiatives such as FDA QbD Pilot Program, PQRI, etc and have published extensively in this field.

Related Publication

Strategic framework for education and training in Quality by Design (QbD) and process analytical technology (PAT)

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Expertise:

  • Oral Drug Delivery
  • Complex Parenterals
  • Paediatric Product Development
  • Regulatory CMC

Paul W Stott

BPharm (Hons) PhD

Director & CEO

Paul W Stott

BPharm (Hons) PhD

Director & CEO

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Paul is an established pharma executive with extensive global experience. Prior to joining Seda he was Vice President, Global Product Development at AstraZeneca, leading a group of over 350 scientists and engineers in the development of all products, manufacturing processes and analytical methods for the AstraZeneca small molecule portfolio.

AstraZeneca Global Product Development has centres in the UK, Sweden, US and China and a network of partnerships with colleagues all over the world and under Paul’s stewardship registered 10 global products.

At AstraZeneca Paul was accountable for the Drug Product CMC component of all Due Diligence assessments and was CMC lead on several multibillion dollar acquisitions. In addition, Paul is a visiting Professor of Pharmaceutics at the University of Manchester, UK and founder of the North West Centre for Drug Delivery (NoWCADD) at the University.

He is a proven senior manager and strategic leader in Pharmaceutical Development with experience across geographical boundaries. Passionate about the development of individual and group capabilities and the application of innovation and scientific rigour to bring new medicinal products to market.

He is recognised within the Industry and with Regulatory Agencies as a driving force in the establishment and realisation of best practice in CMC Quality by Design.

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    Expertise:

    • DMPK and Dose Selection
    • Pharmacokinetic Modelling
    • Complex Parenterals
    • Regulatory CMC
    • Clinical Pharmacology

    Paul A Dickinson

    BPharm (Hons) PhD

    Director & Co-Founder

    Paul A Dickinson

    BPharm (Hons) PhD

    Director & Co-Founder

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    Paul has held several senior science leadership roles in Academia and Large Pharma.  These roles focused on applying the best science in projects to ensure optimal product performance in the patient, thus bridging pharmaceutical and clinical disciplines.

     

    Immediately prior to founding Seda Pharmaceutical Development Services Paul was Senior Clinical Pharmacology Scientist at AstraZeneca and led the clinical pharmacology program to NDA/MAA for AZD9291/osimertinib, which had been awarded ‘breakthrough therapy’ status by the FDA.  Formerly Paul was a Principal Scientist within Pharmaceutical Development (AZ) leading both the global biopharmaceutics network and the Medicines Evaluation science community (USA, SE, UK).

     

    Paul has been at the forefront of recent advances in the understanding of in vitro performance criteria that assure product performance in the patient including clinically relevant dissolution specifications (CRDS).  Paul has co-authored papers with FDA staff focussed on efforts to combine biopharmaceutics with ICH Q8 (BioRAM) and is past Chair of the AAPS ‘QbD and product performance’ focus group.

     

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      Expect a reply typically within 48 hours.

      Expertise:

      • Oral Drug Delivery
      • Complex Parenterals
      • Paediatric Product Development
      • Regulatory CMC
      • Analytical Sciences

      Marcel de Matas

      BSc (Hons) PhD FRSC CChem

      Director & Co-Founder

      Marcel de Matas

      BSc (Hons) PhD FRSC CChem

      Director & Co-Founder

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      Marcel has a track record in a range of management and senior scientific positions in industry and academia. Most recently he was a Principal Scientist in Product Design and Innovation at AstraZeneca, where he was responsible for introducing the latest science, new technologies (advanced drug delivery and manufacturing) and product design thinking into the Product Development group.

      Marcel has led technical activities, provided project leadership and has managed product development teams responsible for the delivery of drug projects from initial concept design through late stage development, regulatory submission and launch (including advanced drug delivery systems). He has led teams at the drug discovery-development interface, assessing the level of chemistry manufacturing and controls (CMC) technical risk and defining product design strategies in early development. Project experience has covered projects across a range of disease and therapy areas with substantial experience in the oncology field.

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        Expect a reply typically within 48 hours.

        Expertise:

        • Oral Drug Delivery
        • Complex Parenterals
        • Regulatory CMC

        Nicola Parisi

        MSc PhD

        Principal Scientist

        Nicola Parisi

        MSc PhD

        Principal Scientist

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        Nicola holds a MSc in Pharmaceutical Chemistry from the University of Messina and a PhD in Pharmaceutics from UCL School of Pharmacy. He is an accomplished Formulation Scientist with 9+ years’ experience in the field and roles at AstraZeneca and GlaxoSmithKline. He additionally holds a qualification from the Association for Project Management (PFQ). He is expert in planning, leading and managing clinical drug product development projects and has a deep understanding of change control, risk and stakeholder management processes.

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          Expertise:

          • Chemical Development
          • Regulatory CMC

          Bill Moss

          BSc (Hons) PhD

          Consultant - Chem. Dev.

          Bill Moss

          BSc (Hons) PhD

          Consultant - Chem. Dev.

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          Dr Bill Moss has over 25 years’ experience as a scientist and leader working in the following areas:

          • Chemical Development and manufacture of clinical and commercial drug substance
          • Expertise in the Discovery interface, Preclinical and Phase1/Phase II development, supporting the progression of new candidate drugs from discovery into development
          • Drug substance project strategy development and integration with drug product, safety and clinical planning
          • Extensive experience of outsourcing drug substance development and manufacture
          • Authoring and reviewing regulatory submissions from Phase I to marketing submissions

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            Expertise:

            • Analytical Sciences
            • Regulatory CMC

            Peter Doyle

            BSc (Hons) MSc PhD

            Consultant - Analytical Sci.

            Peter Doyle

            BSc (Hons) MSc PhD

            Consultant - Analytical Sci.

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            Peter has worked in the pharmaceutical and healthcare sector for over 25 years with leadership and scientific positions at J&J, AstraZeneca and Glaxo. He has extensive experience in the management of outsourced projects with a focus on analytical development activities. Peter has authored many regulatory submissions from FiH to NDA / MAA and has an expert understanding of the regulatory requirements at each stage of development. He has been a consultant to the biotech sector since 2017.

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              Expect a reply typically within 48 hours.

              Expertise:

              • Regulatory CMC

              Roy Jamieson

              BPharm (Hons)

              Consultant - Regulatory CMC

              Roy Jamieson

              BPharm (Hons)

              Consultant - Regulatory CMC

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              Roy is an experienced Pharma Industry & Regulatory CMC professional having spent time as a quality assessor at MHRA and with over 25 years in large pharma organisations leading numerous small molecule projects from FTiH through Marketing Authorisation and launch. As an Independent Consultant he has worked with many small companies as well as collaborating with consultancy firms and is currently supporting the South African Agency (SAHPRA) as a Quality/CMC reviewer supporting their generic backlog programme.

              Roy has successfully led 4 major global submissions through Phase 3 to marketing authorisation approval. His key area of regulatory scientific expertise and interest centres on biopharmaceutics aspects of solid oral dosage forms of small molecules and the bridge between quality performance and the pharmacokinetic profile linked to safety and efficacy.

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                Expect a reply typically within 48 hours.