Regulatory Publishing & Submission

The journey to becoming a top player in the pharmaceutical and allied sectors, requires a focused team, cutting edge research and development, smart diversification and global brand building. While your company may be able to acquire the right talent and resources, we understand that a strong global presence is only possible with approvals and certifications from the relevant health authorities (HAs). Approvals and certifications allow you to export your valuable products into established, as well as emerging markets, around the world.
Our tireless focus on staying updated with regulatory changes as well as submission formats and procedures, results in error free submissions. We ensure that your valuable resources and man-power aren’t wasted on repeat applications or rejections.

We provide regulatory publishing and submission services in the following formats

510(k) Pre Market Submission

A premarket submission, made to a Health Authority, to exhibit the safety and effectiveness of a medical device and that it is substantially equivalent to a legally marketed device.

ASEAN Common Technical Dossier

ACTD is the format for the preparation of applications that will be submitted to ASEAN regulatory authorities for the registration of pharmaceuticals for human use.

Drug Master File

A document submitted by a drug manufacturer to relevant regulatory and health authorities, providing confidential and technical information about the drug, manufacturing facilities, processes, packaging and storing of human drugs.

Electronic Common Technical Document

An e-format for submission of regulatory information to health and regulatory authorities.

Non-eCTD Electronic Submission

An alternative navigation based e-format for submission of regulatory information to health and regulatory authorities.

Paper Submissions

While most health authorities (HAs) have shifted to electronic formats, some HAs still require submissions in the paper format as part of their approval processes.

Product Information File

A submission whereby a manufacturer provides details to a Health Authority which includes the Cosmetic Product Safety Report, details of manufacture (in accordance with GMP) and, proof of the effect.

Pre Market Approval

An approval process based on scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

Regulated Product Submission

A documentary standard, designed to smoothen information flow and review, to and by health authorities and regulatory bodies.

Structured Product Labeling

A documentary markup standard that defines the content required on human prescription drug labels.

Technical File/ Device Master File

A confidential submission to Health Authorities whereby details of the device, manufacturing facility or process are provided.

Our services in this regard ensure a high degree of confidentiality, rigorous quality checks, error free submissions, quicker approvals, reduced costs and increased transparency.

Our Regulatory Publishing & Submission services extend globally, including but not limited to the following markets

EUROPE

European Medicines Agency (EMA)

  • National Procedure
  • Centralized Procedure(CP)
  • Decentralized Procedure (DCP)
  • Mutual Recognition Procedure(MRP)
  • Medical Device CAPs (Conformity Assessment Procedure)
  • Medical Devices CE Marking
  • Cosmetics TF (Technical File) submission
  • Biological/ Biosimilar/ Recombinant Biologics Marketing authorization
  • Active Substance Master File(ASMF)

JAPAN

Pharmaceutical and Medical Device Agency (PMDA)

  • New Drug Application(NDA)
  • Generic Drug Application
  • Medical Devices
  • Cosmetics
  • Biologicals
  • Drug Master File (DMF)

USA

US- Food and Drug Administration (US-FDA)

  • Investigational New Drug (IND)
  • New Drug Application (NDA)
  • Abbreviated New Drug Application (ANDA)
  • Biological License Application (BLA)
  • Over the Counter (OTC),
  • DMFs
  • Originals, Amendments, Supplements & Annual Reports
  • Periodic Adverse Drug Experience Report (PADER)
  • Briefing Book
  • 510(k) Pre-market Notification
  • Pre-market Approval (PMA)

CANADA

Health Canada

  • New Drug Submission (NDS)
  • Supplement to a New Drug Submission (SNDS)
  • Supplement to a New Drug Submission – Confirmatory (SNDS-C)
  • Abbreviated New Drug Submission (ANDS),
  • Supplement to Abbreviated New Drug Submission (SANDS)
  • Drug Master File (DMF)
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AUSTRALIA

Australian Therapeutic Goods Administration (TGA)

  • Market Authorization Application (MAA)
  • Category 1 -For New Chemical Entity (NCE) or for New Indication
  • Category 2 – when application approved in two acceptable countries
  • Category 3- Involves change to a product that is already registered on the Australian Register of
  • Therapeutic Goods(ARTG)
  • Conformity Assessment Report
  • Drug Master File (DMF)

REST OF THE WORLD

 

Respective submissions as per the country specific guidelines that cover the following:

  • New Drug Application(NDA)
  • Drug Master File (DMF)
  • Generic Drug Application
  • Medical Devices
  • Cosmetics
  • Biologicals

 

Submit an application today!