PharmDev Innovations

Regulatory framework

You don''t want to concede victory to complexity of regulations and guidelines and difficulties in getting the requirements into practice, do you ?

We assist you in getting your procedures and organisation for pharmaceutical and clinical development GxP compliant. We make sure that you get your organisation manageable with regard to time and ressource requirements (e.g. people, equipment, cost).

We are your guide through the labyrinth of requirements such that you will ask yourself, why you haven' t made use of this help already before.

No regulatory challenge during development is to really shock us - being it transfer of requirements into practice, training of relevant personnel or taking over some (or all) operational functions.

Did you know - for example - that the "new fashioned" and "vexatious" need for a DoE in ICH Guideline Q8 is anything but "new fashioned" ?

Methodology nowadays called DoE is well known since 1937 (!). Since at that time computers and pocket calculators weren't avalaible yet, it must be possible to make use of this methodology just with paper and pencil.

We'll show you in minutes, how it works.

Example: EU GCP Regulation and IMPs

GCP Regulation 536/2014 is casting its shadow with numerous new and derived rulings.

Respective demand for consulting has shown that only very few of our clients have succeeded in looking through this jungle.

Do you know, what a "Delegated Act" and an "Implementing Act" are in EU legislation ?

Are you familiar with the differences between "Regulation", "Commission Guideline" and "Directive" ?

New draft rulings have been published in all of these categories in combination with the EU GCP Regulation with relevance for IMPs having considerable practical and regulatory impact on both the EU and the national level.

The current EU-GMP Annex 13 is obviously target for being "killed" and replaced by a Detailed Commission Guideline. Furthermore the Directive 2003/94 is planned to be replaced by a (or is it two ?) Delegated Act(s).

Article 63 Manufacturing and import of GCP Regulation reads:

"1. ... The Commission shall be empowered to adopt delegated acts in accordance with Article 89 in order to specify the principles and guidelines of good manufacturing practice and the detailed arrangements for inspection for ensuring the quality of investigational medicinal products ..." which resulted not only in the delegated act itself but also in drafting a detailed commission guideline to replace Annex 13.

If you feel the need to discuss this further or want to have individual support in this regard please do not hesitate to send us a e-mail

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