We recognize the complexities of managing a daily life science enterprise and have places of experience which include just about every aspect of R&D, functions, regulatory affairs, good quality, and manufacturing.
Intertek’s pharmaceutical and healthcare consultants deliver help whatsoever phases of item progress to clients in the pharmaceutical, biotechnology and health-related unit fields.
Receiving a observe of deficiencies following an audit by a regulator is rarely pleasant. For a few organizations, it will necessarily mean significant remediation initiatives are demanded, for Other people it might suggest having to deal with a few compact issues. Our GMP consultants can help you prepare your GMP Audit Response.
Outsourcing of regulatory affairs pursuits is going up as firms realize there are extra efficient ways to deal with their scientific demo systems and achieve efficiencies in their regulatory submissions course of action. This may be accomplished as a result of both full outsourcing, partial out-sourcing or in the vicinity of-shoring solutions.
For the outset in the regulatory venture if a manufacturer has established that there is no legally marketed predicate product to base a 510(k).
With more than 20 years of knowledge with FDA, Overall health Canada, EU and global regulatory agencies globally, Regulatory Compliance Associates® features major pharmaceutical consultants. We’re one of the several pharma consulting firms which can help you navigate the troubles related to market restrictions.
We’re one of the number of pharma consulting firms which can help you navigate the issues affiliated with market regulations.
The rules process surrounding pharmaceutical organizations could be challenging for even the most professional field veteran to be aware of. Just one misstep could imply substantial and Long lasting outcomes for your small business.
GMP consultants with QA knowledge know how Just about every Section from the Group interacts With all the production processes and devices. QA authorities get more info have a whole image in mind when developing a quality administration procedure and so are exceptionally professional in federal, regional, and Qualified expectations.
We provide the experience and Global experience to deal with significantly complicated high-quality demands by way of GMP-compliant design and answers, high-quality documentation and validation in tasks.
Creating IQVIA’s positions on essential trends inside the pharma and everyday living sciences industries, having a center on EMEA.
Our professional staff of regulatory specialists will let you identify your regulatory tactic and detect your ambitions and specifications to meet People ambitions; no matter whether that be filing in distinct jurisdiction (As an example EMA, FDA, international & area market), finishing registration dossiers rapidly and which has a higher volume of good quality, make sure regulatory compliance in a particular current market or standard global regulatory affairs activities.
We offer registration strategies and aid with submissions for corporations who wish to supply goods to your Australian market place but are Not sure from the regulatory specifications.
IQVIA Decentralized Trials deliver reason-built medical services and technologies that engage the right sufferers wherever They can be. Our hybrid and totally Digital answers are actually employed more than any Other folks.