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
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
DRUGS
Test License
Export NOC
Dual NOC
Manufacturing License
Form-29 test batch
Wholesale license
Free sales certificate
Investigational New Drugs (IND)
New Drug Approval(NDA)
Subsequent New Drug Approval(SND)
Special Code/ Neutral Code for Export
Toxicity Studies
BA/BE Studies
Authorized Agent/Registration Holder Support
Market Authorization
Registration Certificate
Import license
Test License
Self life Extension
Re-registration
Rule-37 permission support
MEDICAL DEVICES
MEDICAL DEVICES
Manufacturing License for non-notified medical devices
Manufacturing License for notified medical devices
Permission to manufacture new medical devices in India
Authorized Agent
Import license for medical devices
Registration of medical devices (form-40,41)
Amendments in registration certificate
Re-registration of medical devices
Permission to import new medical devices in India
DIAGNOSTIC KITS
DIAGNOSTIC KITS
Procuring manufacturing license from State licensing Authority(SLA) and Central Licensing Approval Authority (SLAA)
Test license for new diagnostic kits
Import license for notified diagnostic kits
Clarification from CDSCO
Import license for non-notified diagnostic kits
performance evaluation
FOOD & NUTRACEUTICALS
FOOD & NUTRACEUTICALS
Import License Holder
Licensing Registration
FSSAI Compliance
Import Support
Categorization of food product as per Food Safety and Standards Regulations(FSSR)
Product Approval
Labelling and claim compliance
Product testing from NABL
Formulation Design
COSMETICS
COSMETICS
Pre-registration Support
Cosmetics registration certificate amendment
Registration Holder/ Authorized agent support
Cosmetics registration and approval
Manufacturing license
Labelling assistance
Re-registration support
BIOLOGICALS
BIOLOGICALS
Clinical Trial Permission
Phase-I, Phase-II and Phase-III
Post approval changes
Marketing Authorization
Test license
NOC for Form-29
Registration
Import license
HERBAL DRUGS
HERBAL DRUGS
Literature review
Protocol design
Clinical trial Application
Import of crude drugs and phyto-pharmaceuticals
AYUSH Application
PESTICIDES
PESTICIDES
Pesticide Registration
Registration of Herbicides
Registration of insecticides
Registration of formulation
Registration of Technical
Import Assistance on RTT
Improvement of shelf life of pesticides and insecticides
Import permit of insecticides for non-insecticidal use
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