Regulatory Compliance Products & Services

  1. Pharmaceutical Compliance Packaging

    Pharma Packaging Solutions helps companies create packaging which deals with dosing regimens, patient instructions, patient record keeping and more. For companies needing unique designs to drive medication adherence, there is in-house Creative Service Team to develop specified artwork.

  2. Pharmaceutical Environmental Humidity and Temperature Probes: HygroClip2

    The HygroClip2 ADVANCED humidity and temperature probes offer you maximum repeatability and an accuracy of ±0.8 %RH and ±0.1 K.

  3. Enterprise Asset Performance Management Software for Life Sciences, Pharma

    Technology, enabled by the Industrial Internet of Things (IIoT), is empowering organizations to shift to a holistic and operations-centric view where proactive and predictive maintenance (PdM) enables front line personnel in life sciences to act before costly failures occur.

  4. Life Sciences Regulatory Compliance Services

    The Schneider Electric team of dedicated industry experts is focused on providing companies with strict regulatory adherence in a timely and cost-effective manner. This includes comprehensive regulatory compliance and validation services, focused on but not limited to, environmental monitoring systems, building management systems, manufacturing, processing and packaging equipment and automated business systems (MES, laboratory, Information Technology). The Schneider Electric offerings also include quality audits and assessments. Our full range of services and solutions are vendor and platform independent, providing organizations with an objective and authoritative view.

  5. USP 232 And USP 233 Elemental Impurities Compliance

    Metrics Contract Services offers a complete elemental impurities program designed to comply with the USP 232 and USP 233 Elemental Impurities proposed chapters which become official on December 1, 2015.

  6. Logistics Audit/Assessment & Engineering Solution Services

    Modality Solutions provides services such as: cGMP readiness assessments, product characterization and stability studies for distribution, controlled-environment logistics process validation, quality management systems and change control, and thermal packaging design and qualification.

  7. Powder Transfer Process

    EZ BioPac is meeting the challenges of biopharmaceutical powder manufacture. The EZ BioPac single-use system is the fastest, most efficient solution. Its larger diameter top opening permits easy filling and fine-tuning of final weight. 

  8. Regulatory Services

    If you need help preparing and submitting your API regulatory applications, Cedarburg Hauser Pharmaceuticals has the knowledge and experience it takes to efficiently guide you through the complexities of the FDA submission process.

  9. Regulatory

    JHP Pharmaceuticals has an experienced in-house Regulatory Affairs department capable of assisting you with Clinical Trial Applications, New Drug Submissions, and Supplements.

  10. Adverse Event Reporting, Safety and Compliance Software

    Adverse event (AE) reporting is a key process point for maintaining safety and compliance. Unfortunately, it’s also incredibly labor-intensive. AE source documents arrive in just about any form—mail, fax, email, even voice records from call centers.