• Dossier Compilation and Submission Dossier Conversion (Non-CTD to CTD, ACTD, eCTD, NeeS, Country Specific or Regional Submission) for ASEAN, MENA, LATAM, EU, CIS, AFRICA, GCC and many row markets.
• CTD Dossier Writing.
• BA/BE Studies & Clinical Trials.
• ACTD Dossier Writing.
• DMF-ASMF Writing.
• Analytical Method Validation for Dissolution, Identification, Assay, Related Substances (Impurity) and Residual Solvent. (HPLC- with chromatogram, UV- with spectrum), Impurity Profile Validation.
• Comparative Dissolution Profile (HPLC- with chromatogram, UV- with spectrum).
• Bio- analytical Validation / Report and Protocol along with ANOVA calculation for BA/BE report.
• Third party Co-ordination for Bioavailability / Bioequivalence studies through well-established study centres for various dosage forms.
• Product information updates (SmPC, PIL and Labelling).
• Patient Safety Update Report, Pharmacovigillence Report, Risk management Plan
• Dossier Audit with Risk Assessment grading.
• Query support for all of above type of documents till registration.

All above services for Pharmaceuticals, Neutraceuticals , Herbal medicines, Traditional Medicines, Unani Medicines products.

List of countries handling presently :

Nigeria, Ghana, Kenya, Rwanda, Uganda, Myanmar, Philippines, Cambodia, UAE, Saudi Arabia, Cameroon, Angola, Niger, Tanzania, Mozambique, Liberia, Madagascar, Burkina Faso, Ethiopia, Togo, Mali, Malawi, Burundi, Botswana, South Africa, Mongolia, Sri Lanka, Bangladesh, Malaysia, Vietnam, Uzbekistan, Tajikistan, Azerbaijan, Kyrgyzstan, Turkmenistan, Armenia, China, Hungary, Iran, Ukraine, Thailand, Romania, Kazakhstan, Indonesia, Georgia, Colombia, Egypt, Yemen, Syria, Russia, Zimbabwe