A SCIENCE TO MARKET COMPANY
A SCIENCE TO MARKET COMPANY
YOUR CLINICAL REGULATORY WRITING PARTNER
We Provide extensive clinical regulatory writing services such as IB, PSUR, Clinical trial protocol, Clinical study reports.
YOUR TRUSTED REGULATORY AFFAIRS PARTNER
We provide you one-stop solution to your regulatory outsourcing services requirements
GLOBAL MARKET REGISTRATION
Our highly experienced experts assist you register your product anywhere in the world
LAUNCH YOUR PRODUCT IN INDIA
We offer comprehensive regulatory solutions from writing to publication and filing of dossiers pertaining to drugs, cosmetics, food, Nutraceuticals, medical devices, biologicals, and diagnostic kits
INCREASE YOUR EFFICIENCY
We understand the value of your time for Market Authorization Application. Our experts proactively provide you with a regulatory strategy to accelerate the market launch of your product
HAVE PEACE OF MIND
Focus on developing your product while we liaison on your behalf with global regulators
OUR SERVICE OFFERINGS
CLINICAL REGULATORY WRITING
CLINICAL REGULATORY WRITING
Pre-study Documents
- Investigator's Brochures and updates
- Clinical Trial Protocols—Phase I to IV
- Informed Consent Documents—Informed Consent Form and Patient Information Sheet
- Clinical Trial Application
- Protocol Posting/Web disclosure
Post-study Documents
- Clinical Study Reports: Synopsis, Abbreviated, Interim, and Final
- Safety/Patient Narratives
- CTD Modules 2.5 Clinical Overview
- CTD Modules 5.2 Tabular Listings of Clinical Studies
- CTD Modules 2.7 Clinical Summaries, ISS/ISE
- Responding to Health Authority Queries
- Customizing Completed Dossiers for Regional Submission
Product Label
- Label Preparation and Updates- Core Data Sheet(CDS), US Package Inserts(USPI), Summary of Product Chacterstics(SmPC), and Preparation of Local Production Documents(LPDs)
- Label QC
Medical Devices
- Clinical Investigation Plan and Clinical Evaluation Plan (CEP)
- Preparation of 510 (k) and Pre-market Approval(PMA)
- Clinical Study Report and Clinical Evaluation Report (CER)
- Preparation of Eropean Conformity(
) Marking Documents
PHARMACOVIGILANCE
CLINICAL REGULATORY WRITING
Pre-study Documents
- Investigator's Brochures and updates
- Clinical Trial Protocols—Phase I to IV
- Informed Consent Documents—Informed Consent Form and Patient Information Sheet
- Clinical Trial Application
- Protocol Posting/Web disclosure
Post-study Documents
- Clinical Study Reports: Synopsis, Abbreviated, Interim, and Final
- Safety/Patient Narratives
- CTD Modules 2.5 Clinical Overview
- CTD Modules 5.2 Tabular Listings of Clinical Studies
- CTD Modules 2.7 Clinical Summaries, ISS/ISE
- Responding to Health Authority Queries
- Customizing Completed Dossiers for Regional Submission
Product Label
- Label Preparation and Updates- Core Data Sheet(CDS), US Package Inserts(USPI), Summary of Product Chacterstics(SmPC), and Preparation of Local Production Documents(LPDs)
- Label QC
Medical Devices
- Clinical Investigation Plan and Clinical Evaluation Plan (CEP)
- Preparation of 510 (k) and Pre-market Approval(PMA)
- Clinical Study Report and Clinical Evaluation Report (CER)
- Preparation of Eropean Conformity() Marking Documents
DRUGS
MEDICAL DEVICES
DIAGNOSTIC KITS
FOOD & NUTRACEUTICALS
COSMETICS
BIOLOGICALS
HERBAL DRUGS
