Registration of medicinal products and CMC writing
- active pharmaceutical ingredients, starting materials, intermediates (DMF, CEP, TDP)
- finished dosage forms (dossier)
Other regulatory services
- evaluation of the quality of DMFs and dossiers in line with current regulatory requiements
- preparation of responses to Deficiency letters (EU, AU, CA, US, JP, ROW)
- counseling on characteristics of registration procedures on international markets (national, DCP, MRP, CP procedures)
- evaluation of routes of synthesis of APIs, starting materials, final intermediates
- setting of GMP starting point of manufacturing process (definition of starting material)
Change Control Management services
- evaluation of changes according to global regulatory guidelines
GMP services
- counseling on establishment of GMP system
Other services
- preparation of analytical documentation
- organizing activities needed for entering into EU market
- registration of medical devices
- registration of cosmetics
- registration of food supplements
- regulatory services for biopharmaceutical products
We have many years of experience in the Pharmaceutical and Biopharmaceutical industry. We have in-depth knowledge in the area of Regulatory Affairs. We are dealing with various requests from Ministries of Health worldwide. We are preparing tailored made documentation and searching for best regulatory solutions while setting further regulatory strategies.
We have experience in many therapeutic areas and we offer following services:
Regulatory Affairs services for Pharmaceutical Industry
Registration of Medicinal products and CMC (Chemistry, Manufacturing and Controls) writing (CTD, eCTD, nonCTD):
a)preparation of Drug Master Files (DMF) for Active Pharmaceutical Ingredients (API), and for Final Intermediates (Modules 2 and 3) according to global requirements (GDUFA, EU,other Ministries of Health)
b) preparation of documentation needed for Certificate of Suitability (CEP)
c) preparation of complete Drug Product Dossiers (detailed knowledge on Modules 2 and 3) for sterile, solids and semi-solids products for DCP, MRP, National procedures, renewals and variations for all countries
d) preparation of Technical Data Packages for Starting materials and Intermediates In addition, compiling of documentation for Modules 4 (literature references) and 5 (Bioequivalence study, Biowaivers, Bridging,…)
Other Regulatory Affairs services:
a) evaluation of routes of synthesis of API, starting material, final intermediate, etc.
b) setting of GMP starting point of manufacturing process (definition of starting material)
c) determination of GMP steps needed for registration of the API and/or Drug product
d) preparation of evaluations and reports for potential genotoxic impurities (in-silico evaluation, ames test,…)
e) preparation of reports for carry-over studies
f) preparation of responses to Deficiency letters (EU, AU, CA, US, JP, ROW)
g) evaluation of alternative API manufacturers for their DMF quality in line with already registered quality of DMFs and/or dossiers
h) comparison of DMF quality between two API manufacturers (already registered and alternative API manufacturer)
i) consultancy on characteristics of registration procedures in EU countries via DCP, MRP, national procedures and in other countries (AU, CA, US, ROW)
j) setting regulatory strategies (global market overview) for products of various therapeutic areas
k) preparation of documentation for line extensions
l) preparation of documentation for SmPCs (Summary of Product Characteristics) and PILs (Patient Information Leaflet)
m) preparation of dossiers according to QbD
n) preparation of variation packages for EU, AU, CA, US, ROW (e.g. type IA, IB, II, grouping of variations, CBE0, CBE30, PAS, …) for submitting of DMF/CEP/FDF changes
Change Control Management services:
a) evaluation of changes according to EU, AU, CH, CA, US, JP, ROW guidelines
b) consultancy on establishment of change control management system
GMP services: consultancy on establishment of GMP system
Other services:
a) preparation of documentation for analytical procedures and validation protocols and reports (upon results)
b) preparation of stability reports (upon results)
c)consultancy on setting specifications for API, API for FDF and FDF in line with in-house, Ph.Eur., USP requirements and in line with country specific requirements
d) consultancy on organizing activities needed for entering into EU market from other countries (e.g. from US, CN, BR, RU,…) (representing individual company on the market, organizing sales, establishing cooperation with top Brand and Generic companies,…) and from EU market into market of other countries (e.g. US, CN, BR, RU,…)
e) offering regulatory services for biopharmaceutical products, medical devices, food supplements, cosmetics,.…