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RegPak BioPharma Consulting is knowledge-based consultancy service having Global expertise. RegPak BioPharma Consulting have hands-on experiences in pharmaceutical and biotechnology industries and interaction with Regulatory agencies Worldwide. The main services offered are:
1.Strategies for Global Filings incl. Biosimilar registration
2.Advice and/or preparation of Global Clinical Trial Authorisation Applications (CTA submissions)
3.Advice and/or preparation of EU/International Marketing Authorisation Dossier (outside EU) incl. Compilation of various Modules for MAA/BLA/NDA/ANDA for both Human as well as Veterinary medicinal products.
4.Variations Applications
5.Advice on Import and Export requirements incl. Clinical Trial Labeling
6.Orphan Drug Applications
7.Arranging Scientific Advice ... Meetings
8.Active Substance/Plasma/Vaccine Antigen/ Device Master Files
9.Registration of Herbal Medicines as well as Food Supplements in EU
10.Technical writing for the following:
-Target Product Profile
-Investigational Medicinal Products Dossier (IMPD)
-Pharmacovigilance Plan incl. SAE Manual
-Risk Assessment and Risk Minimisation Plan
-Benefit and Risk Assessment
-Annual Safety Updates
-Periodic Safety Update Reports
-Briefing Book for Scientific Advice
-Summary of Product Characteristics (SPC)
-Package and Label
RegPak BioPharma Consulting also assist/represent non-EU companies in getting Small and Medium Sized Enterprise (SME) companies SME status which is newly introduced EMEA initiative. A few benefits (but not limited to) of having this status are:
a.90% fee reduction on scientific advice, inspections, services (up to 100% if the drug is an orphan medicine)
b.100% fee reduction on administrative services
c.Assistance with translations of the product-information documents submitted in a centralised application for marketing authorisation- EMEA will carry out the required on-pack translations
RegPak BioPharma Consulting can also assist in establishing the required quality assurance documentation in-house i.e., SOPs and Policies. Read more
1.Strategies for Global Filings incl. Biosimilar registration
2.Advice and/or preparation of Global Clinical Trial Authorisation Applications (CTA submissions)
3.Advice and/or preparation of EU/International Marketing Authorisation Dossier (outside EU) incl. Compilation of various Modules for MAA/BLA/NDA/ANDA for both Human as well as Veterinary medicinal products.
4.Variations Applications
5.Advice on Import and Export requirements incl. Clinical Trial Labeling
6.Orphan Drug Applications
7.Arranging Scientific Advice ... Meetings
8.Active Substance/Plasma/Vaccine Antigen/ Device Master Files
9.Registration of Herbal Medicines as well as Food Supplements in EU
10.Technical writing for the following:
-Target Product Profile
-Investigational Medicinal Products Dossier (IMPD)
-Pharmacovigilance Plan incl. SAE Manual
-Risk Assessment and Risk Minimisation Plan
-Benefit and Risk Assessment
-Annual Safety Updates
-Periodic Safety Update Reports
-Briefing Book for Scientific Advice
-Summary of Product Characteristics (SPC)
-Package and Label
RegPak BioPharma Consulting also assist/represent non-EU companies in getting Small and Medium Sized Enterprise (SME) companies SME status which is newly introduced EMEA initiative. A few benefits (but not limited to) of having this status are:
a.90% fee reduction on scientific advice, inspections, services (up to 100% if the drug is an orphan medicine)
b.100% fee reduction on administrative services
c.Assistance with translations of the product-information documents submitted in a centralised application for marketing authorisation- EMEA will carry out the required on-pack translations
RegPak BioPharma Consulting can also assist in establishing the required quality assurance documentation in-house i.e., SOPs and Policies. Read more
Other Products
- Medical Product Consulting