Kellerman Consulting came into the rescue for me soon after working with another competitor who still left me in the dark. I had been so relieved to find a liable, professional consulting organization who could assistance a new operator out in developing a complete blown HACCP program - and teach me along the best way!
As your associates, Regulatory Compliance Associates can negotiate the probable minefield of regulatory compliance and regulatory due diligence with Perception, hindsight, as well as the very clear advantage of our exclusive knowledge and practical experience.
Proprietary talent variety of former FDA and market gurus amplified by a company lifestyle of responsiveness and execution. About Overview
Zero Defect: Developing an item which has no defects but making certain the quality benchmarks and reducing the defects to a level of zero inside the projects.
Qualification of premises, amenities and machines as well as the preparing on the corresponding documentation
The definition of your scope to get analyzed may be the responsibility of your client. In case of thorough hole analyses, the GMP/GxP advisor executing the analysis may endorse clarification of interfaces or transitions between person analyses.
From R&D to provide chain and functions to each facet of commercialization, pharma and biotech providers must execute flawlessly throughout all dimensions should they hope to win.
We are able to produce uncomplicated engineering prototypes which are tailored towards your useful and location needs and check here advise Price tag-successful methods that adjust to regulatory prerequisites. The subsequent venture definitions will likely website be defined all through basic engineering:
Besides parenterals PJC Pharma Consulting can supply an array of assist for other dosage types, from candidate choice by to NDA/MAA submissions, both For brand new chemical entities and solution line extensions (PLEs) of a number of oral dosage formulations: Tableting
This and the exact description of the necessities and procedures enables the adequate adaption in the equipment to the real will need of the GMP technique.
- We ensure that your plant website meets your small business objectives though staying thoroughly compliant with the most up-to-date Excellent Producing Follow polices and criteria.
Talent Administration Helps to establish a human resource base that will meet the specialized and managerial need to have of expanding business targets.
PJC Pharma Consulting provides a shopper-concentrated pharmaceutical consultancy and parenteral consultancy company, providing technical steering for item improvement, instruction, important approach evaluations, audits and venture management. With thirty decades’ knowledge during the pharmacy/pharmaceutical market, we include a spectrum of tasks from generic portfolio enhancement and registration to machine growth and registration, and new chemical entity development to medical stage.
Regulatory Compliance Associates High quality consulting consists of assessments, tactic, implementations, staff augmentations, and identification of quality metrics to make certain steady improvement. Our pharma consultants realize the strategic imagining required to align your organization needs and objectives.