FDA Inspected

FDA Inspected

BECRO has been inspected by the US FDA, and the outcome of the inspections was positive: "No regulatory violations were found during the inspections."

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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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Good Laboratory Practice

Good Laboratory Practice

BECRO's affiliated bioanalytical laboratory is GLP Certified

Services

Our Services

BECRO operates by providing high quality Services to Pharmaceutical industry

Conducting Clinical Trials

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

ΕΟΦ

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

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

Location

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BECRO is participating as Exhibitor in CPhI Frankfurt 2025 (October 28-30), Stand 9.2C82.

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

Bioequivalence-Pharmacokinetic 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 for data integrity and compliance with 21 CFR Part 320 - Bioavailability and Bioequivalence (BE), and the outcome of the inspections was positive with No Observations. Also, FDA has inspected Clinical Facilities where BECRO conducts Therapeutic Equivalent studies (especially, studies for Inhalers). No Form-483 was issued.