Two Hats Regulatory Science
We specialise in providing pharmaceutical regulatory science resources and services to the profit and non-profit research and development community.
- Industry:
- Pharmaceuticals
- Type:
- Business partnership
- Size of company:
- 1-10 employees
- Employees on XING:
- 2
- Job Offers:
About us
A niche regulatory science and pharmaceutical services consultancy, based in Hamburg, Northern Germany.
Our primary specialities are:
REGULATORY SCIENCE:
- Life cycle management in particular:
* Quality variations
* Renewals
* Decentralised procedure - management of national submissions
- Phase I/IIa clinical trials, regulatory authority and research ethics committee submissions
- Parallel import and distribution applications
Other areas of expertise:
* Manufacturing transfers (especially involving contract manufacturing)
* Interim Management
* Writing CTD 2.3.P. quality overall summaries
* Paediatric clinical trials
We have a particular interest in prescription, pharmacy only and other medically important pharmaceutical preparations in a clinical care setting (hospitals, clinics).
SCIENTIFIC SERVICES:
- Scientific writing for regulatory and academic sectors e.g.
* Clarity, readability and English grammar review
* Scientific feedback prior to, and after submission to peer-reviewed journals
* Translation of regulatory and scientific documents (German or English)
- Applying for WHO Certificates of Pharmaceutical Products (CPP)
* If required their legalisation at embassies
- Legalisation of key regulatory documents at chambers of commerce/Embassies e.g.
* Certificates of Conformance for EU Class I medical devices
* GMP certificates
* Declarations
Our primary specialities are:
REGULATORY SCIENCE:
- Life cycle management in particular:
* Quality variations
* Renewals
* Decentralised procedure - management of national submissions
- Phase I/IIa clinical trials, regulatory authority and research ethics committee submissions
- Parallel import and distribution applications
Other areas of expertise:
* Manufacturing transfers (especially involving contract manufacturing)
* Interim Management
* Writing CTD 2.3.P. quality overall summaries
* Paediatric clinical trials
We have a particular interest in prescription, pharmacy only and other medically important pharmaceutical preparations in a clinical care setting (hospitals, clinics).
SCIENTIFIC SERVICES:
- Scientific writing for regulatory and academic sectors e.g.
* Clarity, readability and English grammar review
* Scientific feedback prior to, and after submission to peer-reviewed journals
* Translation of regulatory and scientific documents (German or English)
- Applying for WHO Certificates of Pharmaceutical Products (CPP)
* If required their legalisation at embassies
- Legalisation of key regulatory documents at chambers of commerce/Embassies e.g.
* Certificates of Conformance for EU Class I medical devices
* GMP certificates
* Declarations
