Ana’s integrated eyesight of Pharmaceutical High-quality Techniques serves her perfectly in collaborating with internal and exterior clients to harmony compliance with functional, suit to be used solutions.
We recognize the numerous concerns and issues you face with your method to reaching GMP compliance in the pharmaceutical, biotechnology, ATMP and medical system producing industries - and we produce practical, achievable and cost-helpful alternatives in your case.
I had arrive at Shelby Foods just 4 months prior to the First BRCGS audit and experienced very little notion what was required for BRCGS. Brian worked with me and patiently answered all my thoughts till I recognized every thing.
At Regulatory Compliance Associates, we offer the pharma consulting knowledge and pharma consultants essential to information you throughout the quality compliance approach.
Qualification of premises, services and tools and also the preparation from the corresponding documentation
"Bettering human well being requires brave thinkers who will be willing to take a look at new Concepts and Establish on successes. Unleash your likely with us.
The QA Office is recognized for policing the regulated processes for the corporate. They ensure compliance is achieved. To be able to work inside the QA Office, somebody needs thoroughness and a spotlight to depth. There is absolutely no substitute for QA practical experience.
Given that 2017, our Very good Manufacturing Practices (GMP) consultants have assisted numerous shoppers through the foods supply chain to obtain GMP Qualified. GMP is a crucial foundational procedure demanded of many brands to be sure merchandise pharma consultants are persistently manufactured to your significant normal.
Would you at present have a necessity and need to fill a Management posture on an interim foundation? Request us about suited profiles for the short term vacancy.
Our authorities performs third party evaluation and gap Investigation with a quantified Software to assess the business’s condition of regulatory compliance. We assistance the businesses in coming up with CAPA for deficiencies elevated by regulatory inspections.
Read through our traits report from the few years back again to review vital pharma concerns that are still at play in the field.
It leads to enhanced sector speed and elevated transparency and accountability during various corporations linked to formulation (across numerous dosage types), API and biosimilar.
PJC Pharma Consulting gives a consumer-centered pharmaceutical consultancy and parenteral consultancy service, offering complex get more info assistance for product or service progress, schooling, significant course of action assessments, audits and challenge management. With 30 a long time’ encounter from the pharmacy/pharmaceutical industry, we include a spectrum of projects from generic portfolio enhancement and registration to unit progress and registration, and new chemical entity advancement to medical section.
We produce custom made initiatives in compliance with FDA / USDA regulatory necessities and GMP certification demands For each and every business enterprise we provide.