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Pharmaceutical Secondary Packaging

Optimal Solutions for the Patient and Trial

PCI offers a host of pharmaceutical secondary packaging solutions ensuring the most effective solution for the specific needs of the patient and trial.

Our secondary packaging technologies include simple and complex kit assembly, cartoning, walleting, child resistance and compliance packaging, over-labeling and expiry date extension, as well as technologies for parenteral and injectable delivery
forms. From the earliest Phase I studies to the largest Phase III and IV studies, we meet the needs of each with scalable solutions that ensure efficient and cost effective supply.

 

 

Secondary packaging technologies include:

Calendarized packaging formats can play a pivotal role in ensuring patient compliance and adherence to medication regimens. PCI offers multiple compliance prompting packaging formats to best address the needs of clinical trials, including ancillary compliance supporting materials. Our in-house design team works closely with clients to create the optimal solution to address patient needs and trial requirements.
We feature many F=1 Child Resistant / Senior Friendly solutions including our proprietary line of packaging including IntuiDose, IntuiPac, DuraPac, AssuraDose, RxBarrier, HingePak, and Compliance in a Bottle (CIAB). We offer a wealth of experience in successfully testing package designs through our in-house design and development services, balancing the requirements for barrier to entry for children with patient friendly accessibility for adults. Our design team provides management to facilitate the entire testing process allowing our customers to focus on study execution.
Precision labeling technologies support parenteral applications including vials and ampoules, syringes and injectable devices, as well as transdermals and eye care applications. We offer extensive experience for demanding product requirements, including refrigerated or frozen storage and light sensitivity.
Patient kits are organized and assembled with precision, ensuring the correctness of contents and location of individual components. Inspections ensure that each and every kit produced meets established standards for patient use. Our design and development services create solutions that balance the needs of the trial and the optimal use of the patient. Global sourcing solutions provide our customers flexibility for total turn-key supply of ancillary components including syringes, swabs, diluent, needles, as well as printed and unprinted components.
We offer sophisticated assembly solutions for even the most complex package assembly, including unique devices for injection or inhalation. Best-in-class technologies ensure complex assemblies are constructed to exacting quality standards.
We feature solutions for device packaging, including rigid and flexible packaging delivery, as well as turnkey sterilization services. We support multi-stage packaging assemblies including complex kitting.

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Explore the PCI Process Phase by Phase

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PRE CLINICAL

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  • Formulation Development
  • Analytical development/characterisation

PHASE 1

PCI Phase 1
  • Formulation Development
  • Analytical Development
  • Drug in capsule/vial technology (Xcelodose)®
  • Phase I product manufacture
  • Tablets/Capsules
  • Blinding via over-encapsulation
  • Phase I packaging and labelling
  • Storage and distribution

PHASE 2

PCI Phase 2
  • Formulation Optimization
  • Dosage Form Process Validation
  • Analytical Testing and Stability Services
  • Phase II Product Manufacture
  • Tablets/Capsules
  • Blinding via over-encapsulation
  • Phase II packaging and labelling
  • Storage and distribution

PHASE 3

PCI Phase 3
  • Comparator Sourcing
  • Scale Up Studies
  • Phase III Product Manufacture
  • Tablets/Capsules
  • Blinding via over-encapsulation
  • Phase III packaging and labelling
  • Analytical testing and stability services
  • Storage and distribution

COMMERCIAL

PCI Commercial Phase
  • Scale up for commercial supply
  • Commercial product manufacture
  • Commercial packaging and labelling
  • Validation services
  • Analytical testing and stability services
  • Product release to market
  • Storage and distribution

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