Pharmaceutical Quality, Regulatory & CMC Consultancy

The pharmaceutical industry has never faced greater complexity.

 

Success today demands more than regulatory knowledge. It requires experienced professionals who understand how science, quality, manufacturing, supply chain management, regulatory strategy, and commercial objectives interact throughout the entire product lifecycle. 

 

We provide consultancy across GMP, GDP, CMC, Regulatory Affairs and Quality Systems for organisations at every stage of that lifecycle. Built upon over 30 years of pharmaceutical industry experience, we support organisations ranging from innovative start-ups and virtual biotechnology companies through to global pharmaceutical manufacturers, CDMOs, wholesalers, importers and marketing authorisation holders. We are here to provide practical, independent guidance that protects your patients, your products and your business.

30+

Years experience

750+

QP'S trained

Former MHRA

Inspectors on our team

Global

Regulatory experience

 

Consultancy across the product lifecycle

 

Our specialist consultants work collaboratively across the entire pharmaceutical lifecycle bringing together scientific understanding, industry experience and knowledge of regulatory expectations. Explore our six key areas of expertise areas:

  •  

    The decisions made during development can have a lasting impact on a products' ability to progress successfully.

    We support development programmes from proof-of-concept through to late-stage clinical development by providing practical guidance that aligns scientific development with future regulatory and commercial expectations.

     

    Our expertise includes:

     

    • Clinical development quality strategy
    • GMP and GDP support for Investigational Medicinal Products (IMPs)
    • Clinical trial supply chain design and oversight
    • Clinical manufacturing quality systems
    • CMC development strategy
    • Process development and scale-up planning
    • Technology transfer planning
    • Regulatory gap assessments
    • Development risk assessments
    • Vendor and contract organisation oversight
  •  

    CMC decisions can affect development timelines, manufacturing strategy, regulatory approval and future commercial supply.

     

    Our consultants bring experience across pharmaceutical development, manufacturing and lifecycle management, helping you make decisions scientifically, operationally and from a regulatory perspective.

     

    Our experience covers small molecules, biotechnology products, vaccines, ATMPs, sterile products, non-sterile products and combination products.

     

    Our expertise includes:

     

    • Pharmaceutical development strategy
    • Control strategy development
    • Critical Quality Attribute (CQA) identification
    • Critical Process Parameter (CPP) determination
    • Quality Target Product Profile (QTPP) development
    • Process validation strategy
    • Continued Process Verification (CPV)
    • Comparability assessments
    • Technical transfer
    • Scale-up and commercial readiness
    • Change management and lifecycle planning
  •  

    A quality system needs to do more than meet a regulatory requirement. It needs to work day to day, support your people and give you confidence that risks are being managed.

     

    We work with organisations to establish, improve and remediate quality management systems that meet global regulatory expectations while supporting operational efficiency.


    Our expertise includes:

     

    • GMP compliance assessments
    • Inspection readiness programmes
    • Quality Management System design and optimisation
    • Data integrity programmes
    • Risk management frameworks
    • Annex 1 contamination control strategies
    •  Annex 11 computerised system governance
    • Supplier qualification programmes
    • Audit programmes and auditor training
    • Deviation, CAPA and effectiveness review systems
    • Quality metrics and management review systems
    • Remediation programmes following inspection findings
  •  

    Outsourcing, global distribution and increasingly complex supply chains can make it harder to maintain oversight of product quality. We help you review your arrangements, identify risks and strengthen the systems and processes supporting storage, transportation and distribution.

     

    Our expertise includes:

     

    • GDP quality systems
    • Wholesale Dealer Authorisation (WDA) compliance
    • Responsible Person (RP and RP(i)) support
    • Supplier and distributor qualification
    • Transportation risk assessments
    • Cold chain management
    • Distribution network design
    • Supply chain investigations
    • Vendor management programmes
  •  

    Regulatory requirements continue to evolve across the UK, EU, US and other global markets.

     

    Our consultancy help you understand not only what regulations require, but how those requirements should be interpreted and applied within practical business environments.

     

    Our expertise includes:

     

    • Regulatory strategy development
    • Regulatory intelligence
    • Gap assessments against evolving legislation
    • Marketing Authorisation lifecycle management
    • Change control and variation strategy
    • Compliance due diligence
    • Regulatory risk assessments
    • Health authority response support
    • Inspection preparation and defence
  •  

    Advanced therapies and biotechnology products bring their own scientific, manufacturing, quality and regulatory considerations.

     

    Our expertise includes:

     

    • Cell and gene therapies
    • Viral vector manufacturing
    • Biotechnology products
    • Monoclonal antibodies
    • Recombinant proteins
    • Vaccines
    • Personalised medicines
    • Advanced Therapy Medicinal Products (ATMPs)

Consultancy that builds capability, not dependency

 

Many organisations face a common challenge - Consultants provide solutions, but internal capability is not developed. Training providers educate teams, but practical implementation remains difficult. Our approach combines both.


We deliver bespoke consultancy alongside targeted capability development, ensuring that improvements become embedded within the organisation rather than remaining consultant-dependent.

 

Training programmes can be tailored for:

 

Person training a team

Qualified Persons (QPs)

Responsible Persons (RPs)

Senior Quality Leaders

Manufacturing Teams

Technical Services

Regulatory Affairs Professionals

Clinical Supply Teams

Executive Leadership Teams

Topics include GMP, GDP, Quality Risk Management, Data Integrity, Regulatory Compliance, Clinical Trials, Validation, CMC Development, Technology Transfer, Inspection Readiness, Advanced Therapies, Sterile Manufacturing and Emerging Technologies.


This integrated approach enables organisations to solve today's challenges while building capability for tomorrow.

 

 

Why choose RSSL?

Innovationaqua@300X

Practical experience gained from decades of operating within highly regulated pharmaceutical environments.

Cosultancy SQUARE

Consultants who effectively communicate their understanding of the science and the business.

Account Manager

Professionals who can move seamlessly from boardroom strategy discussions to detailed technical investigations.

Qualityaqua@300X

Independent advice focused on patient safety, product quality, regulatory compliance and sustainable business performance.

Meet our consultants

Peter Deegan

Peter is an experienced Pharmaceutical QA professional, with over 30 years GMP, ISO 9001 Quality Systems, audit and training experience. Peter is adept at working with a cross-slice of people to drive a positive ‘Quality Culture’, from shopfloor to boardroom and is passionate about passing on his personal experience to others, through education, coaching, mentoring and training.

Rob Hughes

Rob has more than 40 years' experience in the pharmaceutical industry spanning various operational, project and senior strategic leadership positions in commercial manufacturing and development QA. With experience of the application of QA across control laboratories, API, solids, creams and liquids manufacture and third-party audit and evaluation, Rob’s knowledge makes him a valued member of our pharmaceutical training programme.

Sue Mann

Sue is an experienced QP with over 40 years in the pharmaceutical industry, specialising in Good Manufacturing Practice. Since founding her consultancy in 2009, she has advised global companies on best practices and operational improvements. An inspiring trainer, Sue can break down complex topics in understandable elements and can provide appropriate training to all career levels.

Rebecca Rutter

Rebecca is a Qualified Person and Responsible Person with expertise in biotechnology products and the provision of support for Advanced Therapy Medicinal Products (ATMPs). She has held director positions at several of the most prestigious pharmaceutical companies where she has specialised in setting up and running greenfield manufacturing facilities, systems, processes, supply chain and achieving strategic business milestones.

Tim Sandle

Dr. Tim Sandle has over twenty-five years’ experience of microbiological research and biopharmaceutical processing. A member of several editorials boards, Tim has written 30 books and over 700 book chapters, peer reviewed papers and technical articles relating to microbiology and pharmaceutical and healthcare sciences.

Donna Connew

With over 30 years of industry experience, Donna Connew is a seasoned QP who has held roles across various quality and development functions. Her expertise spans stability and method development, process technology, GMP auditing, incoming materials QC, supplier quality, production QA and clinical trial QA. Since becoming a QP in 2001, Donna has worked extensively in the generic pharmaceutical industry and as a contract auditor for API facilities.

Andy Martin

With over 35 years of pharmaceutical industry experience, Andy began his working life as a Microbiologist in 1985, later progressing to QA Microbiology Manager. During his long career, Andy has gained experience in across a wide range of QA and QC activities. In 2003, Andy become RSSL’s Pharmaceutical Training Manager with responsibility for providing insightful commercial training courses for those looking to enhance their knowledge and prospects.

John Spenn

John is a quality expert with over 25 years in the biopharmaceutical and life sciences industries. He has held senior roles in quality management, regulatory processes and validation (CQV) lifecycle for equipment, facilities, utilities, sterilisation and computer systems. Currently a Director at Dorset Quality Services, John provides validation and quality consulting.

Tony Orme

Now an independent consultant, Tony has 32 years' experience in the regulation of pharmaceuticals with the MHRA, with 22 years within the MHRA Inspectorate leading onto several high profile and complex inspections. Tony has been involved in the development of most UK GDP policies and has a deep understanding on the practical application of GDP, the medicines supply chain and the Human Medicines Regulations.

Neil Wayman

Neil has over 30 years of experience in technical and quality assurance management, specialising in custom pharma quality systems, GMP remediation and transformational change. A trained microbiologist, Neil is an expert in global supply chain management, third-party oversight and Quality Management Systems. Since 2021, Neil has been an independent consultant with RSSL, specialising in GMP training, leadership, inspection management, as well being a mentor for Qualified Persons.

Nick Brand

A proven leader in the pharmaceutical industry, Nick has built a distinguished career driving quality, compliance, and business excellence across global operations. With a foundation in QA and extensive experience spanning QC, Production, MS&T (NPI) and Change Projects, he brings a holistic understanding of how organisations can achieve sustainable compliance and performance.

Mark King

Mark brings unparalleled insight into what QP assessors expect. As the former Vice Chair and Chair of the Royal Society of Biology QP Assessment Panel, he has assessed many QP candidates and understands precisely how medicinal chemistry knowledge is evaluated at viva. He leads the course framework, QP scenario exercises, and sessions on clinical knowledge application, HBELs, cross-contamination control, and facility design.

Sion Wyn

Sion is a recognised authority in computer system validation, compliance and international regulatory standards. A key member of the team behind the FDA's Guidance on 21 CFR Part 11 Scope and Application, Sion later received the prestigious FDA Group Recognition Award for the impact he had made.

Have a pharmaceutical challenge?

 

Let's talk about what you need. Tell us what you are working on and we will connect you with the right expertise.

 

Whether you need help with a specific quality or regulatory issue, support with a larger programme, training for your team or a combination of consultancy and training we are happy to discuss your requirements.

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