Design and style trials with enriched affected individual populations and regulate patient recruitment conditions to reinforce precision and speed
Our group of experts has effectively performed several gap analyses in over the last twenty years and features this consulting provider for all GMP programs.
Our mission should be to speed up innovation to get a much healthier environment. Alongside one another, we could fix consumer troubles and enhance client life.
An in-focus check into The nice Production Apply (GMP) audit globe And exactly how the idea of remote or virtual audits, a reasonably new principle is staying adopted.
Kellerman Consulting held my hand every single stage of just how (and trust me I desired it)! Kellerman Consulting received me by way of all of my approvals with an very easy to observe HACCP system that appeased a USDA regional manager.
“Kellerman Consulting was professional, productive, and continues to indicate their assist and advice even once the GMP audit”.
program have been excellent. In the course of the get more info audit it gave me self-assurance recognizing we experienced everything consistent with BRCGS prerequisites.
This really is causing a power shift with new entrants (frequently not driven by gain) disrupting the incumbents.
We strive to assist strengthen results and create a more healthy, much more sustainable world for individuals all over the place.
Our industry experts performs 3rd party evaluation and gap analysis that has a quantified tool to assess the corporate’s state of regulatory compliance. We assistance the businesses in designing click here CAPA for deficiencies elevated by regulatory inspections.
We fully grasp the complexities of running a everyday living science business enterprise and possess locations of experience which include each individual side of R&D, operations, regulatory affairs, excellent, and producing.
It results in improved industry pace and amplified transparency and accountability through numerous organizations involved in formulation (across many dosage varieties), API and biosimilar.
cGMP is actually a action-up from GMP specifications and is required for dietary nutritional supplement manufacturers. cGMP means Present-day Fantastic Manufacturing Follow. cGMP polices demand more solution screening and much more complete top quality administration programs in position.
It’s a pharma consultancy founded by regulatory compliance executives in the pharmaceutical sector. Just about every pharmaceutical field marketing consultant around the Regulatory Compliance Associates crew knows the exclusive interior workings with the regulatory procedure.