Novotech, the leading Asia Pacific centered biotech CRO today announced the acquisition of CBR International, a global product development, clinical oversight and strategic regulatory operations group.

CBR was founded in 2002 as a consultancy company focused on assisting biotechnology and pharma companies navigate FDA requirements from early-stage development through to approval.  CBR adds a group of experts to Novotech to provide US and global regulatory, scientific, quality, and clinical development services. 

CBR’s specific regulatory expertise and services include long-range Regulatory Strategy and Writing, FDA Representation, eSubmissions, and Scientific Affairs to support requirements for cGMP commercial product development.

The acquisition will further strengthen Novotech’s capabilities in regulatory strategy and US FDA interactions and submissions including IND, IDE, NDA, BLA, Fast-Track, Break-through, and Orphan Drug Applications.  

Novotech CEO Dr. John Moller said:

“CBR will provide decades of FDA regulatory experience for our biotech clients.
They have experience across all product types and are highly regarded for their IND expertise having managed approximately 80 INDs through all phases of development.

This acquisition, together with Novotech’s existing regulatory affairs capability, creates a large global group of experts in toxicology, drug development, and global regulatory submissions support.

This regulatory expertise benefits our US, European, and Asia Pacific biotech clients as they progress through the US clinical environment and navigate often complex FDA requirements.”


CEO and Founder of CBR, Dr. Jeanne Novak said:

“We are extremely pleased to be joining a company the size and calibre of Novotech which brings global demand for our regulatory expertise. The US is an important region for global biotech and pharma companies as part of their clinical program development.   We have the experience and track-record of directly supporting US approvals for over 10 programs.  Navigating novel product development and achieving multiple approvals has built our expertise to support the complex development needs of clients worldwide which will now support Novotech clients.

We look forward to working with Novotech clients to support their drug development programs in the US and globally.  We are excited to continue working with our clients and bringing Novotech expanded services to our colleagues”.

Novotech has decades of biotech drug development experience, exceptional site and investigator relationships, access to vast patient populations, and a project management approach focused on problem-solving, ownership and flexibility. Consistent investment in advanced training and technology combines to deliver a specialist full-service biotech CRO solution.

Novotech has recently been recognised with significant CRO awards including the Asia-Pacific Biotech CRO of the Year by Frost & Sullivan, benchmarked as a top 10 CRO among the world’s leading CROs, a finalist in the prestigious Scrip awards, and has just been awarded the Gene & Cell Therapy Excellence Award. 

In Asia Pacific Novotech has more than 50 Leading Site Partnership agreements with major medical research institutions which delivers exclusive benefits for sponsors.

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노보텍은 글로벌 full-service CRO이자 임상 과학 자문 기업으로서 모든 임상 단계에서 바이오텍 및 제약회사의 신뢰받는 파트너로 자리매김하고 있습니다.  

아시아 태평양, 북미, 유럽 전역에 걸쳐 30개 이상의 지사와 5,000개 이상의 임상시험기관 파트너십을 보유하고 있으며, 다양한 환자 집단에 대한 최적의 접근성을 바탕으로 삶을 변화시키는 치료제의 성공적인 시장 진입을 지원하고 있습니다.  

고객 중심 서비스 모델을 통해 노보텍은 인재, 프로세스, 기술을 유기적으로 통합하여 혁신적인 치료제를 보다 신속하게 시장에 도입하는 데 기여하고 있습니다. 또한, 진정한 파트너십 접근 방식을 바탕으로 고객의 성공, 혁신 역량 강화 그리고 전 세계 의료 발전을 향한 노보텍의 확고한 의지를 실천하고 있습니다.  

노보텍은 19년 연속 Frost & Sullivan의 ‘Global Biotech CRO Award’를 비롯한 다수의 글로벌 어워드를 수상하며, 임상시험 운영 및 혁신 역량의 우수성을 공식적으로 인정받고 있습니다. 심층적인 치료 및 규제 전문성, 현지 시장에 대한 인사이트를 바탕으로 노보텍은 임상시험의 전반적인 효율성을 향상, 데이터 분석의 최적화 그리고 정밀한 환자 모집 전략 수립을 통해 고품질의 임상시험 운영을 실현하고 있습니다. 

노보텍은 과학적 진보를 바탕으로, 글로벌 건강을 개선하는 혁신 치료제 개발을 실현하는 것을 사명으로 삼고 있으며, 앞으로도 바이오텍 및 제약회사의 성공적인 임상 개발 여정을 함께할 것입니다. 

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