At Regulatory Compliance Associates, we provide the pharma consulting experience and pharma consultants essential to guideline you from the top quality compliance process.

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Our mission is always to speed up innovation for your much healthier entire world. With each other, we will solve shopper challenges and strengthen client life.

Anxious your excellent procedure will not reflect FDA anticipations? Connect with former FDA and market professionals who definitely have in depth understanding of FDA's present-day inspection strategies and anticipations that transcend the words and phrases of regulation.

Kellerman Consulting held my hand every single stage of the way (and belief me I needed it)! Kellerman Consulting obtained me through all of my approvals with an easy to adhere to HACCP approach that appeased a USDA regional manager.

“Kellerman Consulting was Expert, successful, and continues to show their aid and assistance even after the GMP audit”.

An on the web and offline checking of QMS at internet site is performed by our professionals via excellent matrices. This Software is significantly valuable for pharma organizations to stay in point out of compliance and all time All set for regulatory inspections.

With in excess of twenty years of working experience with FDA, Health Canada, EU and world regulatory businesses worldwide, Regulatory Compliance Associates® provides main pharmaceutical consultants. We’re on the list of click here number of pharma consulting businesses which will help you navigate the troubles connected to sector regulations.

In combination with parenterals PJC Pharma Consulting can give a wide array of assistance for other dosage forms, from applicant choice through to NDA/MAA submissions, each For brand new chemical entities and product or check here service line extensions (PLEs) of a variety of oral dosage formulations: Tableting

I couldn’t have questioned for an improved organization to help you us Focus on our certification. They had been handy, academic, and received our system successfully transformed with apparent professionalism.

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A company makes use of a discrete measurement often called an functions critical effectiveness indicator (KPI) or metric to track and assess the performance of its ongoing operations. These KPIs help administration in identifying which operational initiatives benefit the Firm and which hinder it.

- The audit report shall be then available in our Audit report database which can be obtainable to any of your respective purchasers. We're going to get permission of your provider prior to sharing stories on the customers.

Prior to the introduction of medicinal merchandise to the industry, the regulations of fine Practice (GxP) should be followed through manufacturing and enhancement.