At Regulatory Compliance Associates, we provide the pharma consulting experience and pharma consultants needed to guideline you from the good quality compliance method.
We fully grasp the various challenges and problems you facial area on your own way to attaining GMP compliance inside the pharmaceutical, biotechnology, ATMP and clinical product producing industries - and we acquire useful, achievable and price-powerful remedies for you personally.
Proprietary talent array of previous FDA and sector specialists amplified by a company society of responsiveness and execution. About Overview
It’s a pharma consultancy founded by regulatory compliance executives from your pharmaceutical business. Each and every pharmaceutical marketplace specialist within the Regulatory Compliance Associates crew understands the distinctive interior workings with the regulatory method.
Therefore, these pursuits have to be planned in detail Using the finish in your mind, including the regulatory, undertaking funding, the long run expansion for the kinds of merchandise Based on supposed business marketplaces in addition to the ability’s country of spot.
Standard Operating Procedures (SOPs) along with all supplementary good quality administration documents (QMS) should be optimally personalized to one another and also to the corporation's organization to permit effective and faultless perform in accordance Together with the respective regulations.
As Section of hazard management and on The premise of regulatory demands, audits have to be completed by adequately experienced personnel in the producer or by 3rd functions on web page within the supplier's premises or by way of questionnaire audits, depending on the criticality of the goods/providers.
In particular, the following features needs to be documented and ensured: description of The interior procedures, the suitability of all premises and services, the conformity of components employed, the qualification in the staff and the caliber of external providers.
Having more info said that elaborate your lifetime sciences source chain, our experienced professionals are right here that can assist you achieve and sustain conclude-to-conclusion GMP compliance according to present and emerging regulations.
I couldn’t have asked for an even better corporation to aid check here us work on our certification. They were useful, educational, and got our method efficiently transformed with obvious professionalism.
In just Valicare GmbH and thru the robust cooperation with our parent business Syntegon complete competencies about classical pharmaceutical and biotechnological generation traces also for advanced therapy medicinal goods and special pharmaceutical, exist.
It brings about enhanced industry pace and improved transparency and accountability during numerous businesses involved with formulation (across several dosage sorts), API and biosimilar.
- The audit report shall be then out there inside our Audit report database which can be obtainable to any within your shoppers. We'll acquire authorization of the supplier in advance of sharing studies into the clientele.
We generate custom made tasks in compliance with FDA / USDA regulatory demands and GMP certification needs For each and every business enterprise we provide.