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JSK RegLink | Regulatory Consulting & Services

JSK RegLink Regulatory Consulting & Services provides global regulatory affairs where submissions are managed scrupulously whilst maintaining an efficient approval rate for biotech and pharmaceutical companies.

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J S K Reglink Limited

Joe Irwin

24 Tentelo●●●●●●●●●●wood Green

Lo●●on , Middlesex, UB2 4LE

GB

44.7●●●●4113
js●●●●●●●●●●@aol.com

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J S K Reglink Limited

Joe Irwin

24 Tentelo●●●●●●●●●●wood Green

Lo●●on , Middlesex, UB2 4LE

GB

44.7●●●●4113
js●●●●●●●●●●@aol.com

View this contact

J S K Reglink Limited

Joe Irwin

24 Tentelo●●●●●●●●●●wood Green

Lo●●on , Middlesex, UB2 4LE

GB

44.7●●●●4113
js●●●●●●●●●●@aol.com

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JSK RegLink Regulatory Consulting & Services provides global regulatory affairs where submissions are managed scrupulously whilst maintaining an efficient approval rate for biotech and pharmaceutical companies.

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1

Why choose us? | JSK RegLink

http://www.jskreglink.com/why-choose-us

44 (0)20 857 43684. We have a proven track record in providing innovative and cost effective support in all aspects of regulatory work to our partners. We also have an ability to deliver bespoke regulatory solutions to meet all clients’ requirements:. Management of all EU procedures (MAA and CTA). New drug applications for generic, herbals, biotech and traditional medicinal products. Advice on filing strategy. Risk assessment for product development plans. Expertise in multiple therapy areas. Statement f...

2

Accessibility | JSK RegLink

http://www.jskreglink.com/accessibility

44 (0)20 857 43684. The JSK RegLink website has been designed and built to be accessible to as wide an audience as possible. Some people with disabilities find using the web difficult and while we know that it is impossible to design a site that everyone can use, if you have problems using our site, please let us know. And we will do our utmost to help. All pages comply with priority 1 guidelines of the W3 Web Content Accessibility Guidelines. Federal Government Section 508 Guidelines. This site uses cas...

3

Our Values | JSK RegLink

http://www.jskreglink.com/our-values

44 (0)20 857 43684. Proven track record in providing innovative and cost effective support in all aspects of regulatory work to our partners. Project Management and support to the generic and non-generic pharmaceutical industry. FDA advises testing for Zika virus in all donated blood and blood components in the US. August 26, 2016. FDA Statement on Medical Device User Fee Agreement (MDUFA). August 22, 2016. August 22, 2016. August 18, 2016. August 11, 2016. August 5, 2016. August 4, 2016. July 28, 2016.

4

Our Services | JSK RegLink

http://www.jskreglink.com/services

44 (0)20 857 43684. We provide a wide range of services for regulatory projects such as;. Registration of NCEs via Centralised, Decentralised, Mutual Recognition and National Procedures. Preparation of Orphan Drug Applications. Training regulatory staff Introduction to regulatory, mentoring and team support. Writing Quality, Non-Clinical and Clinical summaries, overviews, expert statements. Preparation and management of applications for Scientific advice EMEA or National. Preparation and formatting to CTD.

5

Why choose us? | JSK RegLink

http://www.jskreglink.com/services/why-choose-us

44 (0)20 857 43684. We have a proven track record in providing innovative and cost effective support in all aspects of regulatory work to our partners. We also have an ability to deliver bespoke regulatory solutions to meet all clients’ requirements:. Management of all EU procedures (MAA and CTA). New drug applications for generic, herbals, biotech and traditional medicinal products. Advice on filing strategy. Risk assessment for product development plans. Expertise in multiple therapy areas. FDA approve...

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