We will provide you expert support with:

Product & Process Design & Development

Quality by Design (QbD)

Chemistry, Manufacturing and Control         (CMC)

Technology Transfer

Regulatory submissions (BLA, MAA, IND, CTA)

Environmental risk assessments for GMOs

Facility design

Quality Management Systems (QMS) Development & Management

We have supported the design and development of a large variety of biologicals and advanced therapy medicinal products (ATMPs); their processes and also their facilities to ensure the most favourable balance of future-proof operational efficiency, compliance and patient safety.

We provide Qualified Person (QP) services and site leadership for advanced therapy medicinal products (ATMPs), such as cell therapy, gene therapy and tissue engineering in the UK and EU.

We have QP certified hundreds of biological and ATMP product types for over a decade. Our leading niche within ATMPs is in ocular ATMPs (including cell therapy, gene therapy, tissue engineering and regenerative medicine (TERM)).

We offer full life-cycle support from early research through to large-scale commercial manufacturing. We’re experienced at dealing with scientific and regulatory uncertainty and working at the cutting-edge.

We have helped many organisations from the earliest concept stages through to global commercial manufacture.

We offer free consultations to discuss your particular needs.

 

We will develop your ATMP business and create the right culture from the initial concept and vision.

We improve quality, productivity, brand, reputation, patient-centredness and customer satisfaction.

We create asymmetric risk-reward ratios to stack the odds in your favour with larger margins of safety for patient protection. This is our highest value.

We believe your customers should always come back but never your products!

Greater quality & productivity

Greater brand & reputation

Greater patient-centredness

Greater customer satisfaction

Greater project management

We support the development of your greatest assets; your people.

We do this with world-class education and training provided by the:

BioPharmaceutiQals Academy Masterclass (BAM)

We also provide succession planning training services e.g. trainee QP coaching and mentoring.

We enable you to attract, recruit, train and retain the best using excellent training systems.

ATMP Expert QP designed & led

Popular & proven system

Regularly updated with the latest advances

We are frequently invited to speak at corporations and conferences on our expertise.

We have also delivered onsite corporate training to multiple companies in the areas of:

Making quality biological and advanced therapy medicinal products (ATMPs)

Investigating Deviations Effectively and efficiently

Quality by Design (QbD)

Good Clinical practice (GCP)

Good Manufacturing Practice (GMP)

We provide comprehensive GMP auditing services. These can be internal audits if we’re integrated into the team or external audits of your suppliers for excellent supply chain management.

We commonly conduct QP-led GMP audits of critical suppliers to provide the greatest assurance from both a GMP expert and also a ATMP expert.

We have proudly provided these services to not just make improvements but also build great partnerships within and outside the company.

Supplier Management

Materials Management

QP Declarations