Pharmaceutical Research & Regulatory Solution
HPMS will Provide Complete Research Solutions for all type of Pharmaceutical Formulations & API Research dossiers like Clinical Trials CT (all types, Phase I- IV), BA/BE Studies, Toxicology Study, PSUR, CTD, ACTD, eCTD, DMF (Open & Closed Part), Analytical Process & Validations, Stability Studies, Manufacturing Process Validation and Formulation Development (F&D), Novel Drug Delivery System (NDDS) and etc. for regulatory approvals with country specific requirement and Guideline for all Pharmaceutical products.
Key Activity
Clinical Research
- Clinical Trials (phase I to IV)
- Clinical Trial Design
- Clinical Data Management
- Biostatistics
- Clinical Supplies
- Bioavailability Studies
- Bioequivalence Studies
- Preclinical Studies
- Toxicological Studies
- Periodic Safety Update Report (PSUR)
Analytical Research
- Analytical Method Validations
- Analytical Method Development
- Dissolution Profile
- Stability Data Studies
- Analytical Report
- Bioanalytical Services
- Product Performance Testing
- Related Substances Report
- Quantitative Analysis
- Physical Analysis
Regulatory Dossiers & Documentation
- Dossier Preparation & Reformation (EU-CTD, CTD, ACTD formats)
- Dossier Compilation & Reformation in CTD format for Russia, CIS, Central & South America, Middle East, Africa, Asia, UK-MHRA,TGA-Australia, MCC-South Africa, Medsafe-New Zealand, ANVISA-Brazil
- Submission Preparation & Compilation for INDs, NDAs, ANDA, BLAs, INADs, NADAs
- e-CTD preparation and conversion
Process Research
- Process Validation
- Formulation & Development
- Novel Drug Delivery System (NDDS)
Scope of the Regulatory Authority
The Regulatory Authority for which HPMS will Provide Complete Research Solution
- DCGI-India
- UK-MHRA,
- USFDA
- EU
- ANVISA-Brazil
- TGA-Australia
- MCC-South Africa
- Medsafe-New Zealand
- And all others….. Country Specific
Scope of the Product Segment
The Pharmaceutical product Segment in which HPMS Provide Research and Regulatory solutions
- Biosimilars
- Immuno-Oncology
- Oncology
- Critical care
- Cardiac
- Anti diabetic
- Anti Cholesterol
- Antibiotics (Cephalosporin, Beta-Lactum, Fluoroquinolones, Macrolides, & all others..)
- NSAID
- Anti-Malarial
- Hepatobiliary
- Haematology
- Hormonal
- Paediatric
- Gynaecology
- Nephrology
- Neurology
- Dermatology
- Gastroenterology
- Respiratory
Scope of Service Countries
HPMS will be able to provide the Conceptual Branding & Marketing solution for
- India
- USA
- Canada
- Australia
- UK
- EU
- Russia
- CIS countries
- Central America
- South America
- Africa
- Middle East
- Asian Countries
HPMS will provide the Regulatory solutions by considering country specific Regulatory requirement and Dossier Formats , Which facilitate the quick approval of the product in respective Country.