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BIOLOGICS

  BIOLOGICS SERVICES

At the forefront of Biologics consultancy, we bring unparalleled expertise and experience to support your needs. Our team of seasoned professionals is dedicated to delivering top-notch solutions that drive your business forward.

 

Why partner with us

As your strategic advisory and support partner, we offer a unique blend of expertise and experience that sets us apart. Our commitment to understanding your unique business and product life cycle needs is unparalleled. We pride ourselves on fostering effective partnerships and supporting our clients from development to commercialisation. Consider us an extension of your team, working seamlessly to make your journey efficient and successful. We stay ahead of the evolving product development landscape by continuously expanding our capabilities and investing in innovation. Our innovative solutions and processes offer increased efficiency, enabling you to achieve a faster development timeline without compromising quality. With us, you can trust our services’ reliability and trustworthiness.

  • We take full ownership and provide a turnkey solution
  • Critical starting material, Drug Substance, Drug Product
  • We have in-house knowledge and capability
  • Seamless collaboration
  • Continuous innovation
  • Tailor-made services to support

Monoclonal Antibodies, Biosimilars, Vaccines, Recombinant proteins, mRNA, DNA, Cell Therapy, Gene Therapy, Blood and Blood components, Diagnostics

Our Biologics services offered, but not limited to, are as below;

CDMO SUPPORT

TECHNICAL TRANSFERS

GMP QUALITY AND TECHNICAL AUDITS, QMS GAP ANALYSIS AND IMPLEMENTATION SUPPORT

VALIDATION – EQUIPMENT, FACILITY, CLEANING, PROCESS AND METHOD VALIDATION

ESTABLISHMENT OF NEW FACILITIES FROM DESIGN TO LICENCING

END TO END SUPPORT FROM PRODUCT MANUFACTURING TO QP RELEASE

PROJECT MANAGEMENT

SUPPLY CHAIN SOLUTIONS

STAFFING SOLUTION INCLUDING ONBOARDING AND TRAINING

UK AND EU IMPORT, QP CERTIFICATION, QC TESTING AND BATCH RELEASE SUPPORT

TECHNICAL AND REGULATORY SERVICES

CHANGE MANAGEMENT AND AUDIT REMEDIATION

SCALE UP SUPPORT