REGULATORY & TECHNICAL DOCUMENTATION

Pharmaceutical Regulatory Documentation Support

5M Biotech India supports pharmaceutical buyers, institutions, distributors, hospitals, and pharmaceutical companies with the documentation required for product evaluation, export, improvement and regulatory review.

The documentation available for a pharmaceutical good can differ by manufacturer, dosage strength, source, destination market and individual transaction.

Our role is to coordinate the relevant documentation, identify what is available for the product and provide the buyer with the required information for commercial and regulatory due diligence.

01 / PHARMACEUTICAL SUPPLY

Documentation Necessary for Pharmaceutical Supply

Pharmaceutical supply often requires more than just a product quotation. Buyers may need quality, product, shipping or manufacturing documents before a purchase, registration or import process can proceed.

5M BiotecH India coordinates documentation based on each medicine and transaction rather than assuming every product has the same document package.

Documentation may include –

  • Product descriptions
  • Certificate of Analysis (CoA)
  • Packing list
  • Manufacturer information
  • Packing information
  • Commercial invoice
  • Shipping documentation
  • Certificate related documents where applicable
  • Import or export documents
  • Destination specific documents
  • Quality related documentation

02 / PRODUCT & QUALITY

Product and Quality documentation

Product and quality documentation includes –


01

Certificate of Analysis

it provides information related to tested product specifications and batch quality.


02

Product specifications

Product specifications may include strength, dosage form, packaging and other technical characteristics.


03

Manufacturer documentation

If needed documents about the manufacturer or factory can be provided to approved buyers and relevant authorities.

03 / MANUFACTURING FACILITY

Manufacturing facility documentation

Our pharmaceutical supplier also coordinated third party manufacturing requirements. Manufacturing facility documentation may include –

  • GMP related credentials
  • Manufacturing licence information
  • Facility certifications
  • Quality system documentation
  • Product manufacturing permissions
  • Technical capability information

04 / EXPORT & SHIPPING

Shipping and export documentation

International supply of pharmaceuticals may require different shipping and commercial documents depending on the product, destination and shipment type.

Export and shipping documentation may include –

  • Shipping documents
  • Certificate related documents where applicable
  • Product and batch information
  • Commercial invoice
  • Packing list
  • Destination specific supporting documents
  • Manufacturer or source information where required
  • Documentation requested by the buyer or importer
  • Export related declarations

05 / TECHNICAL DOCUMENTATION

Technical documentation

5M Biotech can support coordination of the technical documentation needed for pharmaceutical projects and regulatory evaluation.

Technical documentation may include –

Stability information

CTD related documentation

eCTD related documentation

Manufacturer documentation

Regulatory correspondence requirements

Technical product documents

Product registration support documentation

06 / IMPORT MARKET

Import market requirements

Regulatory requirements vary between different countries. Before a pharmaceutical supply transaction is finalized, the destination market, buyer status, product category and applicable import requirements may need to be analyzed.

Requirements may include –

  • Import permissions
  • Buyer or importer credentials
  • Packaging
  • Labelling
  • Product documentation
  • Customs documentation
  • Storage and handling requirements

07 / INSTITUTIONAL & TENDER

Institutional and tender documentation

Government, procurement and institutional pharmaceutical supply can involve specific commercial and technical documentation.