Regulatory Products & Reviews

LGC AXIO Proficiency Testing operates a wide range of clinical schemes and programs, so whatever your quality needs, AXIO will deliver the confidence in your results that you are looking for.

Empower™ 3 Method Validation Manager (MVM), an option for Empower 3 Chromatography Software, allows you to perform chromatographic method validation, from protocol planning through final reporting, in one application.With Empower 3 MVM you can automatically: Manage method validation workflow in one comprehensive, automated application Clearly display the status of ongoing validation studies – enabling you to see at what…

Resolian has established itself as a world-class leader in biopharmaceutical drug development through analytical excellence with over 500 scientists across three global labs.

Tests 5 physical parameters of virtually all tablet shapes

Temporarily not available for purchase.

Tailored bioanalytical services for preclinical to clinical studies, primarily for large molecules, biosimilars, peptides, and oligonucleotides.

Ready 4 Action, proprietary feasibility assessment, sets the cornerstone of a cost-effective product development plan. Ready 4 Action is the four-step process used to evaluate the viability of proposed drug products. This important tool enables clients to make the go/no-go decision regarding a given drug's market potential and clinical development feasibility.Armed with the neccessary intelligence, uncover with Ready 4 Action…

Camargo ensures the appropriate regulatory requirements are met every step of the way, streamlining your drug development process all the way to approval.Ready to guide you through the preclinical stage of drug development, Camargo provides strategic support in the following areas: CRO selection Study design Study setup and execution Project management In clinical program development, camargo's focus is unwavering:…

Superior Regulatory Service Helps Transform Your Clinical Trials. Strong regulatory strategies are pivotal in getting products to market. While many countries’ drug regulations are similar, there are still significant differences. These similarities and differences are the basis of a global regulatory strategy that encompasses the needs of all regions. Serving you where you need to be, our Regulatory Affairs teams are located…

ProBioGen holds a manufacturing authorization for GMP (Good manufacturing practice) compliant manufacturing and batch release of biotechnological drug substances and fulfills all present regulatory requirements by EMA and FDA. GMP Manufacturing Services include: Manufacturing of pre-clinical and GMP grade material Disposable bioreactor Technology, stirred tank bioreactors - Decreased risk of cross contamination - Reduce…

Learn how to perform a gap analysis of laboratory quality activities to help your laboratory meet minimum QMS requirements.