In the course of the merchandise everyday living cycle of the medicinal solution, top quality prerequisites maximize repeatedly from study and enhancement through the different scientific phases to sector maturity.
We’ll perform along with you to definitely implement your GMP certification software, making certain you understand how to operate it and which you go your next audit.
Proprietary talent selection of previous FDA and industry professionals amplified by a corporate culture of responsiveness and execution. About Overview
We recognize the complexities of working a lifestyle science company and have locations of expertise which include each individual facet of R&D, functions, regulatory affairs, quality, and producing.
Our pharmaceutical consulting Experts will develop a custom made tactic based upon your merchandise and business’s particular person demands. Our regulatory compliance clientele contain:
Unparalleled abilities: Our consultants have wide industry experience and an insider’s standpoint from their time as GMP inspectors. They've got stood on each side from the GMP compliance equation, offering them with a unique comprehending that informs just about every assistance we offer.
Regulatory affairs is Regulatory Compliance Associates spine. We exceed other pharma consulting corporations with sector professionals expert in complexities of the pharmaceutical and biopharmaceutical industries.
Assured offer chain with competent suppliers and sturdy procedures is eventually The idea for lessening grievances and making certain medicinal item safety.
Making over a rich heritage of acquiring AI for healthcare, IQVIA read more AI connects the appropriate data, technology, and expertise to address the unique requirements of Health care. It can be what we call Health care-quality AI.
- We ensure that your plant web-site fulfills your organization goals even though currently being completely compliant with the newest Good Production Exercise regulations and specifications.
Laura with Kellerman Consulting is simply great. She is rather useful, uncomplicated click here to operate with and received us as a result of our GMP audit with a far better rating than we anticipated. Also, the Business of every one of the paperwork Kellerman Consulting offered us with is excellent.
Combining extremely experienced experts and thoroughly refined procedures with our earth-course technological innovation.
PJC Pharma Consulting offers a customer-targeted pharmaceutical consultancy and parenteral consultancy assistance, providing technological guidance for product improvement, training, critical method assessments, audits and venture administration. With 30 many years’ experience during the pharmacy/pharmaceutical sector, we deal with a spectrum of assignments from generic portfolio enhancement and registration to machine advancement and registration, and new chemical entity growth to medical stage.
When you are from the strategy of making ready for an internal, external, or forthcoming regulatory inspection, we will assistance you with entire dedication and Expert abilities by our skilled and experienced consultants.