Pharmaceutical Regulatory Services

“Ensure compliance and streamline processes with Zedkey Global Connect’s Pharmaceutical Regulatory Services. Trust us for expert guidance and efficient solutions tailored to your needs.”

Regulatory affairs support that goes beyond submissions

Zedkeyglobalconnect has worked in every clinical specialty and has the leadership and expertise to get your safe and effective product(s) to market. Our risk-balanced approach and strategic direction contribute to positive business impacts and set your organization up for greater success.

Analytical Services​

We offer wide variety of Pharmaceutical Testing Services with the help of various analytical testing laboratories monitored by dedicated professionals. Our services include Chemical Analysis, Finished Product Analysis and Analytical Method Development with Validation as per ICH guidelines.

We maintain direct line of communication between our clients and analytical facilities to ensure that all testing is performed to the fullest of customer satisfaction.

  • Analytical Method Development
  • Validation
  • Analytical Method Transfer

Legalization

Certain products that are exported require certain documents along with the registration as per the regulations of the importing country. Some of the documents like Power of Attorney, GMP Certificate, COPP, or any other Documents related to pharma be Attested/Notarized/Legalized from the Embassy (Ministry of External Affairs) of the importing country in exporting country.

We have a specialized team that focuses on all the legal Documentations, Notarizations, Attestations, Apostillation, and Legalizations.

Artwork Design​

Our Packaging design specialists will help you in the development of packaging to suit your individual products. Our creative packaging designers and production resources use years of design experience to provide you with superior service and value.

Our Team offers you package and display ideas that will grab the end user’s attention and motivate them to buy your products.

  • Folding Boxes / Cartons
  • Patient information Leaflets (PIL) / Inserts
  • Label
  • Carton
  • Blisters
  • Tubes
  • Sachets
  • Booklets

CTD Dossiers

PREPARE, REVIEW AND SUBMIT

Format: CTD Guideline (EU / ICH / ROW)

  • Module 1 – Administrative Information and Prescribing Information
  • Module 2 – CTD Summaries (Quality Overall Summary, Nonclinical & Clinical Overview)
  • Module 3 – Quality (S part – DMF & P Part – Finished Product)
  • Module 4 – Nonclinical Study Reports (Literature-Based)
  • Module 5 – Clinical Study Reports (Literature-Based)

ACTD Dossiers

PREPARE, REVIEW AND SUBMIT

Format: ASEAN CTD Guideline

  • Part I – Administrative Information and Product Information
  • Part II – Quality (S part – DMF & P Part – Finished Product)
  • Part III – Nonclinical Study Reports (Literature-Based)
  • Part IV – Clinical Study Reports (Literature-Based)

ROW Dossiers

PREPARE, REVIEW AND SUBMIT

We prepare & review dossier as per country specific guideline.
ROW Dossier cover below parts

  • Administrative and legal Part
  • Quality Part
  • Clinical and Toxicity Part
Scroll to Top