FDA Inspected

FDA Inspected

BECRO Ltd was inspected by US FDA, recently, and the outcome of the inspection was positive: "No regulatory violations were found during the inspection."

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GCP

GCP

BECRO operates according to the GCP and ICH guidelines, the Declaration of Helsinki and all currently standing rules and legislation governing regulatory and ethical aspects whenever ...

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ISO 9001:2015

ISO 9001:2015

The Quality Management System (QMS) of BECRO Ltd has been assessed and approved by IQS Standards Division. The registered scope of the QMS is: Contract Research ...

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Welcome to BECRO

An independent contract services organization (CRO) founded by professionals with research & clinical experience in academia, regulatory authorities & pharmaceutical industry in order to promote excellence in clinical research

Location

Location

BECRO is based in Greece and Cyprus, which are European Union members, and all our activities are subjected to inspections by European & National Regulatory Authorities

Services

BECRO operates by providing high quality Services to Pharmaceutical industry

Conducting Clinical Trials

ΕΟΦ

BECRO was approved by ΕΟΦ (EOF), the Hellenic Organization for Medicines, a member of EMA, in Conducting Clinical Trials after evaluation according
to current legislation

EOF Registration Number:
118-C-17

Medical Advisor Services

A panel of medical advisors provide services in: haematology, oncology, cardiovascular diseases – hypertension, nephrology, autoimmune diseases – rheumatology, gynaecology, dermatology, pulmonary diseases, metabolic disorders – diabetes mellitus – osteoporosis, neurology, ophthalmology

ISO 14155:2011

ISO-14155

ISO 14155:2011 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes. It specifies general requirements intended to protect the rights, safety and well-being of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the results, define the responsibilities of the sponsor and principal investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices

Standard Operating Procedures

All provided services are according to a set of Standard Operating Procedures (SOPs), embraced by all members of the Organization

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CPHI Milan

CPhI Milan 2024

BECRO is participating as Exhibitor at CPhI Milan 2024 (8-10 October), Stand 24D44.

BECRO is specialized in the conduct of

  • Therapeutic Equivalent (Non-Inferiority) studies (Bioequivalence studies with Clinical End-points) for Topical Generic products:
    • Ophthalmic (leading CRO in Europe),
    • Inhalers,
    • Dermatological,
    • Anesthetics and NSAIDs,
    • Suppositories,
    • Nasal,
    • Otic
  • Bioavailability and Bioequivalence studies
  • Superiority studies for Generic products
  • Clinical investigations for Medical Devices

BECRO offers clinical trials services all the way from study set up to submission.

In addition, BECRO specializes in drafting modules of CDT and CERs for Medical Devices, and in preparing CDT and CDISC
for US FDA submissions.

BECRO has been inspected by US FDA twice, and the outcome of the inspections was positive with No Observations.
FDA conducted these inspections to “ensure that data and information submitted to FDA by BECRO are scientifically valid
and reliable” and to determine whether the activities and procedures of BECRO complied
with 21 CFR Part 320 - Bioavailability and Bioequivalence (BE).

BECRO invites you to our Stand 24D44 for discussing possible collaboration. Please suggest a time for our meeting at your convenience.

Register now and receive a FREE Access Pass!