Chemistry, Manufacturing and Controls
We are proud to be global leaders in every aspect of CMC.
In a world where compliance is essential, our expertise ensures our clients' products remain so throughout their lifespan.
Chemistry, Manufacturing and Controls
Quality can never be compromised
Compliance matters
At G&L Healthcare Advisors, our CMC RA professionals utilize decades of experience gained with clients at every stage of development to guarantee their products are manufactured, tested and controlled to exacting standards in the face of continual change.
From the raw materials and the manufacturing sites to the equipment being used or even the packaging design and specifications, change is a constant in regulatory affairs and failure to comply with it can have detrimental consequences.
Our CMC experts ensure ever-changing requirements are always met through the design and delivery of structured compliance programmes, giving our clients one less thing to worry about and more time to focus their essential resources elsewhere.
Support at every stage of the process
Our CMC experts ensure nothing is left to chance
Pre-Approval/Registration
At every stage of your product's lifecycle, compliance is essential. Our global expertise is central to creating client-specific CMC strategies and guidance. We then utilize our services and solutions and decades of experience in working with Health Authorities throughout the world to meet their exacting requirements and ensure compliance every time.
Post-Approval Maintenance
Compliance is an ongoing process and requires constant attention. Failure to do so can lead to fines, reputational damage and inevitable supply issues. Change is a constant and varies depending on the product and Health Authority. With decades of CMC experience and unrivaled relationships with global Health Authorities, our experts are ready for all eventualities.
Special Projects
Nobody likes surprises and when it comes to maintaining compliance, preparation and planning are key. Our experts utilize experience and insights gained in every aspect of Regulatory Affairs and from working with global Health Authorities to ensure continued compliance is a given and not left to chance.
Committed to compliance
Keeping up with change can be incredibly resource-intensive.
At G&L Healthcare Advisors, our industry-leading CMC experts design and deliver essential support and services specific to every client’s needs to ensure their products remain compliant throughout their entire lifespan.
We don’t just achieve approval for our clients’ products – we make sure they remain compliant throughout their lifespan.
From start-ups to Fortune 100 companies, our knowledge and experience of health and regulatory requirements around the world, coupled with our global insights, give our clients a vital competitive edge that allows them to concentrate on essentials like product development and company-wide growth, safe in the knowledge G&L is maintaining their CMC compliance at all times.
CMC matters
While it seems like an obvious statement, CMC compliance is absolutely essential. CMC plays an integral role in enabling nonclinical and clinical studies and reducing a product’s time to market.
Furthermore, it is regarded as a mark of quality and a clear indication that the drug is:
- Safe and effective;
- Consistently meeting required regulatory agency standards; and
- Labeled appropriately.
As the requirements and expectations of health agencies change with time, CMC ensures products always remain safe and compliant with these.
CMC is as an ongoing process and an integral element of drug development and the global regulatory landscape’s evolving structure.
Even before the product reaches trials, the quality-control process is already in full effect and remains so throughout the product’s entire life.
From where it is made and the raw materials used, to their continued testing and monitoring, as well as their storage and consistency of efficacy, every detail matters when it comes to sustained CMC compliance.
The requirements of regulatory and health agencies are always changing.
Coupled with this are the changes and progress that will inevitably impact the product manufacturing process.
From having to rectify the differences to fines, the withdrawal of the marketing authorization, reputational impact, or even the suspension of product distribution on a national or regional level, non-compliance can be hugely damaging.
Our CMC experts ensure compliance is never an afterthought and always first and foremost in everything they do.
