|
|
|
| home > white papers > Key to Outsourcing Method Development and Validation: A Pragmatic Approach - RSSL |
|
|
 WHITE PAPERS |
|
RSSL
|
+44 (0)118 918 4024
|
|
http://www.rssl.com
|
|
University of Reading, Whiteknights Rd, Reading, West Berkshire RG6 6LA
|
|
|
Key to Outsourcing Method Development and Validation: A Pragmatic Approach
|
|
In an industry that is seeing an increasing level of work being
outsourced, the Contract Research Organisation (CRO) of choice needs to
have proven experience in both the pragmatism and flexibility of the
method developer’s mind set and a regulatory background in validation.
As
companies are focussing on achieving ever shorter times of drug to
market, it is vital that a tailored, pragmatic approach is adopted when
engaging in both method development and validation activities for an
Active Pharmaceutical Ingredient (API) or drug product (DP).
Although
methods still require a high degree of robustness, the overall strategy
should encompass a full evaluation of the regulatory requirements
applicable to the particular phase of the drug life-cycle; this is
pivotal in Key to Outsourcing Method Development and Validation A
Pragmatic Approach order to ensure a successful regulatory submission,
where the applicant must demonstrate suitable validation of all methods
used to support the filing.
|
|
|
|
|
|
|
|
 |
News and Press Releases |
 |
Mogrify enters research collaboration with the MRC Laboratory of Molecular Biology
Cambridge, UK, 11 January 2021: Mogrify Limited (Mogrify®), a UK company aiming to transform the development of ex vivo cell therapies and pioneer the field of in vivo reprogramming therapies, and the MRC Laboratory of Molecular Biology (LMB), a world-class research laboratory dedicated to understanding important biological processes at the molecular level, today announced an exploratory research collaboration. The project aims to develop novel protein expression systems by leveraging recent advances in direct cell reprogramming to help improve the production of proteins which are not produced sufficiently well in existing expression systems.
More info >> |
|
 |
White Papers |
 |
|
Investigator Portals: Facilitating and Streamlining Communication & Collaboration with Study Sites
ArisGlobal
ArisGlobal LLC
Investigator site personnel are often frustrated with the lack of transparency and communication with their sponsors, leading to significant dissatisfaction and withdrawal from current and future studies. The adoption of investigator portals gives sponsors a platform that fosters collaboration and improves site management. Learn about five key areas of sponsor-investigator site interactions deserving of electronic communication and collaboration. Technology and design aspects are also covered.
More info >> |
|
 |
Industry Events |
 |
DIA Europe 2021
15-19 March 2021, VIRTUAL CONFERENCE
DIA Europe is the must-attend event for all life science professionals
working in drug development, from discovery to marketed use. It
encourages open collaboration by bringing together representatives from
the entire spectrum of the life science landscape and facilitating
crucial discussions across several topic tracks: Clinical Development,
Regulatory Strategy, Pharmacovigilance, Value and Access, Health Policy,
and many more.
More info >> |
|
|
|
