Below is a complete list of services offered by our company. For any further details, please contact us, and we would gladly provide you with the same.
| Covering EU, APAC,
RUB (CIS) |
Covering EU and APAC |
For Companies
|
For Authorities
|
| Get product release
for EU and APAC and RUB markets. Liaise for appropriate contacts to
serve for North- and Latin American submission |
|
Provide long term project
assistance or short-term advisory
- Provide training in EU regulations
- Provide training on APAC regulations
- Provide training on RUB regulations
- Advise on the compilation
of complex submission files
- Review your submission files
for suitability
- Assure compliance for GHTF,
AHWP and ASEAN regulations
- Training in STED and CSDT
submission format
|
Provide long term assistance or short-term
advisory
- Provide training in EU regulations
- Review submission files for
compliance
- Training in STED and CSDT
submission format
|
Act as a direct
extension of your Regulatory Affairs department, we can
- Provide you fulltime staff
- Augment your existing staff
- Fill in for absences
- Cover any emergency in work
overload
- Provide oversight
- Write, execute, and submit
Design Dossiers / Type Examination Files / Change Notifications
- Manage Post-Market Surveillances
- Assist in bring troublesome
situations into compliance
- Review, or help write clinical
evidence
- Perform literature search
and write literature based clinical evidence
|
Act as a direct extension of your
Regulatory Affairs department, we can
- Provide you fulltime staff
- Augment your existing staff
- Fill in for absences
- Cover any emergency in work
overload
|
Tailored Regulatory
Affairs Services
- Answer questions by phone
and email
- Come on-site for meetings
and any necessary on-site development and research efforts
- Meet with third party vendors
and suppliers on the clients behalf
- Review third party contracts
and advise for regulatory compliance (Suppliers and service providers)
- Meet with the Authorities
- Analyze situation in collaboration
with your company’s management
- Develop or optimize strategic
regulatory plans
- Help to overcome regulatory
compliance obstacles
- Assist with Import/Export
Issues
|
Tailored Regulatory Affairs Services
- Answer questions by phone
and email
- Come on-site for meetings
- Help to overcome regulatory
compliance obstacles
|
Provide advice and hands-on support for approval and compliance strategies, including
- Risk Analysis and Essential Requirements / principles
- Technical Documentation
- Labelling and Language Compliance
- Liaison with Regulatory Agencies and Notified Bodies
|
Review of, advise in and provide hands-on support for approval of:
- Risk Analysis and Essential Requirements / principles
- Technical Documentation
- Labelling and Language Compliance
|
- Act as your EC representative
- Co-ordinate your field corrective actions
- Prepare submit and co-ordinate your clinical investigations
|
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