Consulting


If you have any areas in which you require assistance, BCC is happy to discuss it with you.

Pharma


BCC is a pharmaceutical advisory company. BCC provides expertise on all pharmacovigilance / safety related activities and documentation for pre and post marketed products and handling various safety issues during the life cycle of drugs. 

 

Independently analyze, evaluate and medically interpret aggregate adverse event data, taking into account underlying disease in assessing causality, managing risk and optimizing benefit/risk of products. BCC conveys innovative approaches to signal detection and data-mining.  BCC provides insight to achieving favorable product safety labeling, offering an external market perspective. BCC is recognized for sound medical judgment and novel alternative methods to problem-solving. BCC has a broad breadth of knowledge and experience in managing global pharmacovigilance activities across all stages of global drug development.

 

BCC`s expertise include  signal detection, evaluation and the management of automated systems, safety data/medical literature analysis; case processing, aggregate safety reports, case reports, medical assessments of adverse event reports, regulatory documents, single case review. The worldwide global industrial expertiese also  include  safety monitoring of clinical trials, working with multidisciplinary  clinical trial teams, submission and registration for new indications, overview of clinical study protocols, medical writing, etc.

MedicaL Devices


Our expertise are based on long term experiences in Project-and Managerial functions in a multicultural environment. in MedTech QM and QA environments; CAPA; Project and People Management, Gap Analysis, Preparation and execution of FDA, TÜV, various EMEA competent Authority Inspections  and International Product Transfers.

BCC can assist you with expertise specialized in Design and Development of value added integrated Management Systems such as  ISO 9001; ISO 13485, ISO 14971,  FDA CFR 21 part 11 and 820; MDD 93/42; IVD98/79 EG; EKAS-Rchtlinie 6508.

Audits and Assessments of Managment systems, Design and Development  of continuous improvement Process and Operating Figures Systems.

 

Furthermore, BCC provides you with high quality technical and administrative advice, help and support. Your confidentiality and security are fully assured as BCC is an independent organisation, there is no conflict of interest.

 

 

 

 

«The wellbeing of humans is more

than just lip service»