Acorn Regulatory February 2018 Newsletter

  2018 has started with a flurry of recruitment activity at Acorn Regulatory as we continue to grow.  There are still a number of vacancies open at the company and you can read them below in this newsletter.  As always, we welcome any thoughts that you may have on the articles that we are highlighting and you can get in touch with us by emailing info@acornregulatory.com

1) 10 Questions To Consider When Moving from A DCP Close Out To Product Launch

For many companies bringing a product to market, the biggest issue to contend with is the matter of finalising the regulatory procedure.  However, for small and medium life science companies that might not have a presence in a particular market, this is not the biggest issue.  The matter of completing national phases in each country and registration with the local health authorities can prove to be difficult and can significantly delay the launch of a product. Read the full article here.

2) Blog: The 30% Club Report & Women in Life Sciences

In this blog, Dr. Gemma Robinson looks at the recent 30% Club report and the similarities that can be drawn between the financial services and life sciences sector in attracting and retaining female participation in the workforce. What can be done to encourage more women to stay in life sciences and progress to senior management roles? Read the full blog article here.

3)Featured Articles from the Acorn Regulatory Top 100 Articles

Our website is visited tens of thousands of times a year by professionals in the life sciences sector.  Recently we took time out to analyse the stats and we have compiled a list of the Acorn Regulatory Top 100 most read articles ever on our website.  You can see the full list and read all of the articles here.

4) A Remote Audit – Could This Be An Option To Prevent Rising Pharmacovigilance Costs?

In accordance with GVP Module I, the MAH is responsible for performing risk-based audits of the quality system at regular intervals including audit of the PV system. The methods and conduct of these audits are outlined in GVP Module IV. Read the full article here.

5) Vacancies: Responsible Person (RP) & Quality Specialist

As part of our ongoing growth, we are now recruiting for a further two positions.  The Responsible Person (RP) and Quality Specialist roles are part of our expansion plans that were recently reported on by industry website MedTech Engine.  Read more about the vacancies here.

6) Ever Changing Regulatory Demands

As regulations and guidelines become broader, more electronic and increasingly data driven, manufacturers must adapt with ever changing regulatory demands. Regulators are shifting more responsibility onto manufacturers to instill quality throughout their operations and throughout their product lifecycles. In the past, small and emerging life sciences companies might have functioned sufficiently with manual processes and disconnected systems, but may now be unable to satisfy the requirements of regulators whose fundamental shift is a growing focus on electronic processes, data driven decisions and increased transparency to information. Download the whitepaper here.

7) Our Pharmaceutical Services

We take the hard work out of regulatory submissions by taking your raw data and transforming it into the appropriate file types that are required by the Competent Authorities. From R&D to Manufacturing through to Distribution, Sales & Marketing personnel, we can liaise with your team to collate the relevant data and create your medicinal product application. Read more about our services here. If you would like to receive the Acorn Regulatory monthly newsletter straight to your inbox then simply complete the webform below and we will send each edition to you on the first Thursday of each month. [ninja_form id=8] You can read back issues of our newsletter by clicking the links below.