Having a merged tenure across our companies of almost two hundred several years and our market-identified scientific and technological abilities, we assistance to make sure the basic safety of about a hundred ninety million patients and healthcare practitioners around the globe yearly.
Our team is made up of a various choice of business veterans and specialists in furnishing practical suggestions in complying with polices in the course of your undertaking lifecycle. Among our specialists, we’re proud to obtain several previous GMP inspectors and sector specialists who carry for the desk their intimate familiarity with the nuances and intricacies of GMP compliance all through a job lifecycle.
- When report essential on urgent foundation to support the provision, regulatory submissions and so forth., When manufacturing site can’t accommodate the audit resulting from hectic timetable, When travel restriction; Sponsor might get benefits by getting our IGAP reviews from our report database, moreover our customers only shell out a little fraction of The prices ordinarily connected with conducting a supplier audit.
At Regulatory Compliance Associates, we offer the pharma consulting expertise and pharma consultants necessary to manual you in the quality compliance process.
Consulting provider: Our expert will Appraise your particular person scenario and provide you with an authority evaluation.
As your associates, Regulatory Compliance Associates can negotiate the possible minefield of regulatory compliance and regulatory homework with insight, hindsight, and the clear advantage of our exceptional experience and knowledge.
A brand new breed of therapies is getting into scientific enhancement. Guantee that your method of drug progress is as modern given that the compound you want to provide to market.
Alex has held management level roles in High-quality Assurance, guaranteeing merchandise top quality & regulatory compliance, and also Senior Specialized Supervisor positions accountable for CMO administration, oversight and tech-transfer of pharmaceutical products and solutions. This encounter equips him very well in evaluating producing techniques for early stage products and solutions, in addition to late section and commercial merchandise for EU and US marketplaces.
With a lot more than 20 years of experience with FDA, Overall health copyright, EU and world-wide regulatory organizations all over the world, Regulatory Compliance Associates® provides main pharmaceutical consultants. We’re one of several handful of pharma consulting companies that can help you navigate the troubles connected with marketplace regulations.
Our entire-time GMP consultants respond right away to all customer concerns, which demonstrates one among our Main values.
ADAMAS’s Very good Producing Observe (GMP) experts can perform To judge devices at your pharmaceutical, biotechnology, or medical system Corporation or at your vendor internet sites to ascertain Should the units in place are adequate to fulfill your producing desires get more info and the current regulatory expectations.
It leads to improved market speed and increased transparency and accountability during a variety of businesses associated with formulation (across various dosage types), API and biosimilar.
The sphere of mobile and gene therapy is evolving speedily and dealing with continued technological, regulatory, and commercialization hurdles.
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