Pharmaceutical Affairs

Global Compliance and Support for Clinical Trials

Biotrial offers a complete range of pharmaceutical affairs services to support clinical trials in the US and France.

Our global team of experts has the experience and expertise to support clinical trials of all types and sizes. We are committed to providing our clients with the highest quality pharmaceutical affairs services.



added values

Our in-house pharmacies are GCP-compliant and offer a wide range of pharmaceutical services for different types of Investigational Medicinal Products (IMPs, new chemical entities, biologicals, ATMPs, herbal medicines, food Supplements, and Medical Devices) including:

  • Drug development: We provide support for all phases of drug development, from discovery to commercialization.
  • Regulatory affairs: We help clients navigate the complex regulatory landscape for clinical trials.
  • Quality assurance: We ensure that all pharmaceutical products and services meet the highest standards of quality.
  • Data management: We collect, organize, and analyze data from clinical trials.
  • Compliance: We help clients comply with all applicable regulations.


Biotrial’s pharmaceutical service oversees all steps of the product process from drug supply, drug import, receipt, storage, accountability, compounding, over-encapsulation, repackaging, relabeling, dispensing, reconstitution of sterile injectable solutions, reconciliation, and destruction or return.

Both of Biotrial’s pharmacies follow the same processes, which can be adapted to follow different regulations in Europe and the USA.


  • GCP processes in place
  • Secured area with limited access
  • All storage rooms (ambient, cold) are temperature, pressure, and humidity-controlled on a 24/7 basis
  • Non-sterile room for over-encapsulation, repackaging, relabeling, oral solution reconstitution
  • Sterile room for the preparation of injectable formulation

American Pharmacy

  • 21CFR regulations, ICH GCP E6, ISO14644 and USP 797 compliant
  • Non-sterile room
  • USP 797 compliant room for sterile compounding with laminar flow hood (ISO 5, sterile) with annual maintenance contract
  • Authorization for Controlled Substances: Drug Enforcement Administration (DEA) Regulations, Schedules 2, 3, 4 and 5 compliant

French Pharmacy

  • French GCP and GMP, ISO 14644 and ICH E6 R2 followed
  • Certified by the Regional Health Agency (ARS) for supplying, packaging, labeling and storage (authorization 05001M)
  • Non-sterile room
  • Controlled room for sterile reconstitution/injectable solution with isolator (ISO 5, sterile) with annual maintenance contract
  • Authorization for Controlled Substances (ANSM)

Drug import

Biotrial provides drug import and European certification services for clinical trials. For drugs not manufactured in Europe, we partner with a Qualified Person (QP) to conduct drug analysis and obtain the European QP release for approval, ensuring compliance with all applicable regulations and the highest standards of quality and safety.

Our expertise

Biotrial’s experienced pharmacists can prepare different dosage forms of Investigational Medicinal Products (IMPs) and Medical Devices, such as tablets, capsules, oral solutions, and injections.

Savoir Faire


We use the same type of capsules, filled with the main excipient only. This ensures that the capsules are consistent in appearance and taste, which can help to improve patient compliance.



We use NaCl for IV or subcutaneous formulations. This is the most common salt used in injections, and it is known to be safe and effective. We also use amber syringes if the drug infusion is colored. This helps to protect the drug from light, which can degrade its effectiveness.



We encapsulate the test tablets in a capsule and make an identical encapsulated placebo. This allows us to blind the study participants to whether they are receiving the active drug or the placebo.

Medical Care

Oral solutions

We mask the taste (acid, bitter…) by using ancillary products such as mint strips, sugar, or bitter solution. This helps to make the oral solutions more palatable for patients.

Sterile drug handling

Biotrial takes great care to ensure that sterile drugs are handled safely and securely. We have a dedicated team of pharmacists who are trained in sterile drug-handling procedures. We also have a state-of-the-art clean room facility that is classified as ISO 7 under positive pressure.

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  • Staff Training
    • Pharmacy staff perform a Klerkit (FR) / Hardyval CSP-media fill comprehensive challenge test
  • Premises
    • Clean Room classified (ISO 7) under positive pressure
    • Separate equipment pass through window and ante-room (under positive pressure)
  • Equipment
    • Isolator/Laminar flow hood (ISO 5, sterile) with an annual maintenance contract
    • Single-use small material
  • Biocleaning processes
    • Specific SOP
    • Microbiological contamination monitoring (contact plates)
    • Particular control

Non-sterile drug handling

Biotrial ensures the safe handling of non-sterile drugs with trained pharmacists and a dedicated preparation room with air extraction.

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  • Premises
    • Non-sterile preparation room with specific air extraction
    • Dedicated to the oral formulations
  • Equipment
    • Non-sterile Flow hood
    • Single-use small material
  • Biocleaning processes
    • Specific SOP
    • Rules to avoid cross-contaminations

Pharmacy team

Biotrial’s pharmacy team is composed of two teams, one located in the US and the other located in the EU. The team works together to ensure the safety and proper conduct of clinical trials. 

Biotrial’s experienced pharmacists can prepare different dosage forms of Investigational Medicinal Products (IMPs) and Medical Devices, such as tablets, capsules, oral solutions, and injections. They have a deep understanding of the pharmaceutical industry and they are committed to providing the highest quality pharmaceutical preparation services.

The pharmacy team is well-experienced and fully trained in Good Clinical Practice (GCP). They can manage all pharmaceutical operations according to client requirements. This includes:

  • Preparing and dispensing investigational medicinal products (IMPs)
  • Monitoring drug stability and quality
  • Conducting drug accountability
  • Complying with regulatory requirements
  • Providing training and support to study staff
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