The smart Trick of GMP consultancy That Nobody is Discussing
The smart Trick of GMP consultancy That Nobody is Discussing
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“Kellerman Consulting acted being a trainer for our new QC seek the services of, so we benefited from that along with the effective planning for your SQF audit. We obtained a ninety eight% within the audit. That should converse for by itself.
We understand the numerous problems and troubles you deal with on your approach to achieving GMP compliance inside the pharmaceutical, biotechnology, ATMP and clinical unit manufacturing industries - and we create sensible, achievable and price-helpful alternatives for you personally.
We help Countless firms, together with 17 of the top twenty five worldwide pharmaceutical, biotech, and clinical machine organizations, link Along with the specialists they need with the optimum workforce model.
An in-aim consider The nice Production Follow (GMP) audit earth And exactly how the thought of remote or virtual audits, a fairly new principle is currently being adopted.
Qualification of premises, amenities and tools along with the planning of the corresponding documentation
To begin the Regulatory Compliance Associates scoping course of action these days, make sure you enter your info while in the blue form under click here and click on the post button at the bottom of the webpage.
The sequence on the tools are customised According to shopper’s enterprise requirement and agony details.Tetrahedron to start with conducts an in-depth audit/observation of current Procedure prior to coming up with the implementation system.
Alex has held management stage roles in Top quality Assurance, making certain product excellent & regulatory compliance, in addition to Senior Specialized Supervisor positions responsible for CMO management, oversight and tech-transfer of pharmaceutical items. This practical experience equips him perfectly in assessing production systems for early section products and solutions, in addition to late stage and business products and solutions for EU and US markets.
Does one at present Have got a need and need to fill a leadership place on an interim basis? Inquire us about suited profiles for your non permanent vacancy.
Building IQVIA’s positions on crucial trends from the pharma and existence sciences industries, which has a concentrate on EMEA.
A group of long lasting GMP consultants, specialised in many fields of competence, supports you with your check here responsibilities and problems with know-how and foresight.
It brings about improved current market velocity and amplified transparency and accountability all through numerous organizations involved in formulation (across many dosage kinds), API and biosimilar.
- 360 degree audit solution To guage the capabilities and quality units of suppliers and out-sourcing associates
It’s a pharma consultancy founded by regulatory compliance executives with the pharmaceutical sector. Each and every pharmaceutical industry guide to the Regulatory Compliance Associates staff is aware of the special interior workings from the regulatory procedure.