Services
We provide wide range of products & services
How can we help you?
Product Sourcing
- Sourcing of the right product from the right company at the right price
- Taking care of all legal formalities
- Regulatory affairs and follow up for documents
- Supply chain aspects, Lead time management & follow up for timely dispatch of consignments
- Quality assurance
Regulatory
- 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
- Clinical Trial Application in DCGI & BE NOC As per New Amendments from DCGI, INDIA
- 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).
Tech Transfer
- Centralized governance and decision making structure.
- Organizational structure.
- Quality assurance and regulatory alignment
- Gap analysis and risk management
- Communications and documentation systems.
- Supply-chain management.
- Project management.
- Process knowledge codification.
Tech Transfer
DMF-ASMF (Type I-IV Compilation, Submission, Writing, Auditing, Life cycle management) Analytical Method Validation Report Compilation, Review (For Active Assay, Dissolution, Identification, Preservative-Assay, Related Substances (Impurity) & Residual Solvent, Bio-assay, Impurity Profile Validation& Includes protocol, Report with HPLC chromatogram or UV spectrum, if whichever applicable) Comparative Dissolution Profile (Protocol, Report with HPLC chromatogram, UV spectrum, if whichever applicable). Patient Safety Update Report, Pharmacovigilance Report, Risk management Plan (Compilation, Submission, Writing, Auditing with Protocol, Report with raw data) Process Validation Services, Protocol & Report Compilation, Review (Tablet All Type, Capsule – All Type, LVP, SVP, Eye drops, Topical, External, Liquids, Implants, powder, aerosols, propellant, Aids & Other all Dosage forms possible).
Dossiere
CTD Dossier Compilation, Submission, Writing, Auditing (For ASEAN, MENA, LATAM, EU, CIS, AFRICA, GCC and many row markets). Conversion of Dossier (Non-CTD to CTD, CTD to pCTD, eCTD to pCTD, ACTD, eCTD, NeeS, Country Specific or Regional Submission) Clinical Trials (Clinical Trial Studies / Pre- clinical trial studies through well-established study centers, Clinical trial report writing, Clinical Trial Application in DCGI & BE NOC As per New Amendments from DCGI, INDIA) ACTD dossier Compilation, Submission, Writing, Auditing (For ASEAN, CIS & Other Applicable markets for Paper ACTD format &eACTD format writing & Submission).
