Backed by scientific and medical experts, we offer the best methodology to keep your R&D fast paced, targeted, efficient and secure
- R&D plans evaluation and development
- SOP’s and protocol development
- Pre-Clinical Pharmacology & Toxicology
- Full R&D lab support
- Product Development
- Method Development and Validation
- Stability Studies
- Characterization Studies
- In-Vitro Bioequivalence Studies
- Production Process Development, Scale-up Manufacturing (cGMP)
- Production of Stability/Clinical BatchesType your paragraph here.
Custom Research
- Small volume high Value compounds/High volume manufacturing
- API’s and their Intermediates
- Complex Intermediates & Molecules
- Reference Compounds
- New Building Blocks for Chemistry Synthesis
- Impurities
- Libraries
- Literature and Non-literature Compounds
In-House Synthetic Chemistry Expertise
- Chiral Chemistry Expertise
- Air-Sensitive and Moisture-Sensitive Expertis
- Metal-Mediated Reactions
- Reductions
- Grignard Reactions
- Birch Reduction
- Halogenated Chemistry
- N Buli
- Multi-Step Synthesis
- Scale-Up to Multi-Kilo Quantitites
Expert and targeted clinical study services and support Clinical Trial Application
- Institutional Ethical Approval
- Budget and site management
- Consent & Approval
- Clinical study/trial management
- Real time data capturing
- Secure data management: validation, storage and archiving
Specialized regulatory support to Pharmaceutical, Biotechnology, Medical Devices, Nutraceutical Manufacturers.
- Health Canada/FDA/EU
- Market Access - Specialty Drugs
- Formulary Listing
- Drug Commercialization
- Regulatory Strategy
- Gap Analysis
- Liaison with Regulatory Authorities (Pre-submission meetings, Dispute Resolution / Market Access Refusals, Waivers / requests)
- Pre-market Clinical Trial Applications
- Drug Master File (DMF) support for active ingredient (API) manufacturers
- Market Authorization Applications for New Drugs, Generics, Biologics
- Post-Market Filings
- Drug Establishment Licensing (DEL), Facility Registration & Listing, Amendments, Annual Reviews & Updates
- Customized Quality Management System (SOPs), Implementation & Training
Research & Development
Backed by scientific and medical experts, we offer the best methodology to keep your R&D fast paced, targeted, efficient and secure
- R&D plans evaluation and development
- SOP’s and protocol development
- Pre-Clinical Pharmacology & Toxicology
- Full R&D lab support
- Product Development
- Method Development and Validation
- Stability Studies
- Characterization Studies
- In-Vitro Bioequivalence Studies
- Production Process Development, Scale-up Manufacturing (cGMP)
- Production of Stability/Clinical BatchesType your paragraph here.
Custom Synthesis
Custom Research
- Small volume high Value compounds/High volume manufacturing
- API’s and their Intermediates
- Complex Intermediates & Molecules
- Reference Compounds
- New Building Blocks for Chemistry Synthesis
- Impurities
- Libraries
- Literature and Non-literature Compounds
In-House Synthetic Chemistry Expertise
- Chiral Chemistry Expertise
- Air-Sensitive and Moisture-Sensitive Expertis
- Metal-Mediated Reactions
- Reductions
- Grignard Reactions
- Birch Reduction
- Halogenated Chemistry
- N Buli
- Multi-Step Synthesis
- Scale-Up to Multi-Kilo Quantitites
Clinical Development
Expert and targeted clinical study services and support Clinical Trial Application
- Institutional Ethical Approval
- Budget and site management
- Consent & Approval
- Clinical study/trial management
- Real time data capturing
- Secure data management: validation, storage and archiving
Regulatory Affairs
Specialized regulatory support to Pharmaceutical, Biotechnology, Medical Devices, Nutraceutical Manufacturers.
- Health Canada/FDA/EU
- Market Access - Specialty Drugs
- Formulary Listing
- Drug Commercialization
- Regulatory Strategy
- Gap Analysis
- Liaison with Regulatory Authorities (Pre-submission meetings, Dispute Resolution / Market Access Refusals, Waivers / requests)
- Pre-market Clinical Trial Applications
- Drug Master File (DMF) support for active ingredient (API) manufacturers
- Market Authorization Applications for New Drugs, Generics, Biologics
- Post-Market Filings
- Drug Establishment Licensing (DEL), Facility Registration & Listing, Amendments, Annual Reviews & Updates
- Customized Quality Management System (SOPs), Implementation & Training