• We need to outsource our bioanalysis but we:

                   Require extra resource - Learn More ...

                   Need the expertise to ensure regulatory compliance - Learn More ...

                   Need to demonstrate effective oversight of our bioanalytical programmes - Learn More ...

                   Want to find the right bioanalytical laboratory for our programme - Learn More ...

                   Have to move our assay to a different laboratory and / or want to realise cost savings - Learn More ...

  • Are your PK assays appropriately built, validated and delivering for the stage of development you are at ? - Learn More ...

  • Are the non-proprietary assays you are using fit for the purpose ? - Learn More ...

 • Do you have a PK assay that needs troubleshooting or revising ? - Learn More ...

  • Is the wording in your clinical protocols compromising your PK bioanalytical requirements ? - Learn More ...

• Have you had issues translating your biomarkers, will they be used as eligibility or patient stratification tools ? - Learn More ...

• Are your biomarker assays qualified and fit for their intended purpose ? - Learn More ...

• Could biomarker sample handling be confounding your data ? - Learn More ...

• Do you need to address immunogenicity in your biotherapeutic of biosimilar programme, are your assays appropriate ? - Learn More ...

 • Do you have difficulty identifying the right couriers for your programme ? - Learn More ...

 • Have sample delivery delays impacted your studies ? - Learn More ...

 • Would you like to expand your bioanalytical network and deliver samples to new geographical locations ? - Learn More ...

 • Are your logistics integrated with your sample management and bioanalysis ? - Learn More ...

 • Do you have enough control over your samples before, during and in that last mile of transit to the consignee ? - Learn More ...

 • Please Click Here to download our Logistics summary sheet.

With over 25 years experience A4P auditors have conducted GxP assessments across Europe, Asia and the Americas. There is little we have not encountered. Quality enhances an organization's reputation and its products. A4P can help you define and measure your performance by designing and implementing quality management systems and GxP audit programmes.

By integrating our Quality Assurance and Bioanalytical expertise, A4P will enhance your audit experience. We can provide a flexible and cost effective QA service including GLP and GCP/GCLP audits, supplier audits, training and pre-regulatory authority inspection preparation.

If you have problems with updating or implementing CAPA's, regulatory deviations, escalating compliance issues or regulatory breaches, A4P has the experience, flexibility and knowledge to help you. Learn More ...

Regulatory documents are a crucial and mandatory part of any drug submission. Easy to review, high quality, regulatory-compliant documents can accelerate regulatory reviews and reduce your overall time to approval.

A4P can provide writing expertise for a range of documents including pre-clinical and clinical study protocols and reports, bioanalytical reports, Investigator Brochures, safety narratives, and manuscripts. All applicable regulatory or journal guidelines will be adhered to.

Outsourcing preparation of these documents will give you flexibility when project timelines change or internal resource and expertise is limited. You can confidently outsource this work to A4P's experienced writers and rely on us to rapidly write high quality documents that can give you a real advantage and be vital to the success of your project.

A4P can assist you with individual reports or manage preparation of a package of reports to meet your needs. contact us for further details.