RSSL launches dedicated pharma consultancy spanning CMC, regulatory affairs and advanced therapies

The science-backed service targets start-ups, virtual biotechs and smaller CDMOs, combining QP-led advisory with GMP laboratory, analytical and training capabilities to support quality and regulatory challenges across the full product lifecycle

Reading Scientific Services Ltd (RSSL) has announced the launch of its dedicated pharmaceutical consultancy service, aimed at helping pharma and biopharma companies navigate increasingly complex quality, regulatory, technical and commercial challenges.

RSSL said the launch was intended to help start-ups, virtual biotechs and smaller CDMOs that may lack in-house expertise or capacity, supporting them across their full product lifecycle.


All pharma firms are facing increased pressure to keep up with evolving data integrity expectations, Annex 1 requirements, increasingly globalised supply chains and the rapid development of advanced therapies and personalised medicines, but these challenges can be particularly difficult for smaller businesses.


RSSL added that the consultancy will not be purely advisory but also science-backed, drawing on its GMP and non-GMP laboratories, analytical testing, R&D and training capabilities.RSSL launches dedicated pharma consultancy spanning CMC, regulatory affairs and advanced therapies

Experienced practitioners will deliver the service, including Qualified Persons, former inspectors, validation specialists, microbiologists and regulatory experts.

The service will span the following six core areas:

●         Product Development
●         CMC
●         Quality Systems
●         Supply Chain & Distribution
●         Regulatory Affairs
●         Advanced Therapies & Biotechnology.

Emily Ness, Head of Pharmaceutical Training & Consultancy at RSSL, said: "Pharmaceutical organisations are operating in an increasingly complex environment, where quality, regulatory and technical challenges can have a direct impact on development timelines, supply continuity and patient access."

We aim to give clients access to the specialist expertise they need at the point they need it, while also helping them build the confidence, capability and systems to manage future challenges more independently.

"By connecting consultancy with laboratory insight, analytical testing, R&D and training, we can help clients move from issue resolution to long-term resilience.”

You may also like