A Secret Weapon For pharma consultants in India
A Secret Weapon For pharma consultants in India
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“We partnered with Kellerman Consulting very early on inside the SQF certification course of action, and by depending on their experience and methodical method of collecting, compiling, and organizing the essential documentation, we have been effective in attaining our certification.
Custom made products and services for each system, with tailor-made procedures built to meet up with very precise demands. We’ve realized a lot about what will work and what doesn’t. Search the newest learnings and insights from our scientific growth professionals.
Our interim professionals are quite versatile, and their function is charged on hourly basis only. A set price tag offer such as all incidentals can be submitted on Exclusive request.
Kellerman Consulting held my hand every move of the way in which (and belief me I essential it)! Kellerman Consulting received me through all of my approvals with the simple to comply with HACCP plan that appeased a USDA regional supervisor.
You should pick out an field within the dropdown record We operate with formidable leaders who would like to outline the long run, not hide from it. Alongside one another, we attain remarkable outcomes.
As Section of chance management and on The idea of regulatory demands, audits should be completed by sufficiently skilled staff in the company or by 3rd events on site for the provider's premises or through questionnaire audits, dependant upon the criticality of the goods/providers.
Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive evidence e-book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues.
Besides parenterals PJC Pharma Consulting can supply a wide range of assist for other dosage types, from candidate assortment by way check here of to NDA/MAA submissions, equally For brand new chemical entities and merchandise line extensions (PLEs) of quite a few oral dosage formulations: Tableting
Our industry experts performs third party analysis and gap analysis with a quantified Software to evaluate the corporation’s point out of regulatory compliance. We assist the companies in developing CAPA for deficiencies elevated by regulatory inspections.
- We be certain that your plant internet site satisfies your online business targets when becoming totally compliant with the most up-to-date Fantastic Producing Apply laws and requirements.
It causes improved current market pace website and enhanced transparency and accountability throughout many companies associated with formulation (across a number of dosage kinds), API and biosimilar.
Regulatory Compliance Associates pharma regulatory consultants will create a comprehensive proof reserve of documented proof demonstrating the corrective motion taken to remediate non-compliant challenges.
When you are while in the means of planning for an internal, exterior, or upcoming regulatory inspection, we can easily assist you with complete motivation and Experienced knowledge by our properly trained and professional consultants.