• House no. 41, Gurunanak Nagar, baltana, Distt Mohali) ,Punjab. India
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Pharma ActD Dossiers
From Formulation Development to Dossier Submission

Welcome to Pharma ActD Dossiers

One partner for pharmaceutical product development, technology transfer and regulatory documentation.

Pharma ActD Dossiers is a specialized pharmaceutical regulatory consulting and documentation company supporting clients worldwide with product development, dossier preparation, technology transfer, clinical study support, and global product registration. With nearly 15 years of industry experience, we assist pharmaceutical, nutraceutical, herbal, veterinary, and medical device companies in preparing CTD, ACTD, eCTD, and country-specific registration documentation for regulated and semi-regulated markets.

Our services cover formulation development, analytical support, technology transfer, regulatory strategy, dossier compilation, bioequivalence study coordination, and product registration assistance across Asia, Africa, GCC, CIS, Europe, Latin America, and other international markets. We work closely with clients to deliver practical, submission-ready documentation tailored to country-specific regulatory requirements.

Discuss your project with us — Call: +91 96256 45858  |  Email: pharmaactddossiers@gmail.com

Our Services

For nearly 15 years, Pharma ActD Dossiers has supported pharmaceutical companies with product development and regulatory documentation. Three primary service lines cover the full lifecycle — quick overview below, with scope, deliverables and support detail further down.

CTD, ACTD and country-specific dossier support

CTD, ACTD and Country-Specific Dossier Support

Submission-ready registration documentation compiled to the format required for your target market.

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Technology transfer services

Technology Transfer

Documentation, planning and coordination to move a pharmaceutical product or process between sites.

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Clinical study support

Clinical Studies

Bioequivalence, bioavailability and regulatory data coordination to support product registration.

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Detailed Service Support
01

Pharmaceutical Formulation Product Development

Move from product concept to a development plan with coordinated formulation and analytical support. We work with your team to understand the product, target market, dosage form, manufacturing capabilities and documentation requirements.

Each project is scoped to the product, available data and applicable regulatory requirements.

Planning a new product? Discuss the scope with us

Support may include

  • Formulation development for the agreed dosage form and project scope
  • Review of target product and development requirements
  • Excipient and process considerations
  • Analytical method development and validation support
  • Development documentation and product specifications
  • Stability study planning and documentation support
  • Coordination of development activities with your manufacturing and quality teams
02

Technology Transfer

A successful technology transfer depends on clear, complete information moving between the sending and receiving teams. We help organize the documentation and coordination needed to support transfer of a pharmaceutical product or process to a new site.

The scope is tailored to the product, sites, available records and client requirements.

Transferring a product or process? Let's discuss

Our support may include

  • Review of available product and process documents
  • Preparation or organization of technology transfer documentation
  • Transfer planning and coordination between relevant teams
  • Review of manufacturing process, analytical methods and specifications
  • Support with transfer protocols, reports and associated records
  • Identification of information gaps for follow-up by the responsible teams
03

CTD, ACTD and Country-Specific Dossier Support

Prepare your product registration documents in a clear, organized format for the intended market. We support dossier compilation and documentation according to the applicable CTD, ACTD or country-specific requirements and the information provided by your organization.

Regulatory requirements differ by country and product. Final data, declarations and approvals remain subject to review by the relevant authorities.

Tell us your target country and product

Dossier support may include

  • CTD and ACTD dossier compilation
  • Country-specific registration documentation
  • Module and document organization
  • Review of supplied technical documents for completeness and consistency
  • Coordination of required product, manufacturing, quality and regulatory information
  • Support with responses and document updates during the review process, as agreed

A Clear, Coordinated Project

1

Share your requirements

Tell us about the product, dosage form, target market, current development stage and the support you need.

2

Define the scope

We review the available information and agree on deliverables, responsibilities and next steps.

3

Work through the documentation

Our team coordinates the agreed formulation, analytical, transfer or dossier activities with your designated contacts.

4

Review and finalize

We organize the agreed outputs for your review and support updates within the project scope.

Own Research Center

Experienced Lab Technicians

Govt. Certified

International & Domestic Patents

Why Work with Pharma ActD Dossiers?

  • Pharma · Nutraceutical · Herbal · Veterinary · Medical Devices
  • CTD · ACTD · eCTD · Country-specific formats
  • Asia · Africa · GCC · CIS · Europe · Latin America
  • Formulation · Analytical · Bioequivalence · Registration
  • Submission-ready documentation, tailored to each market
15 plus years of focused practice

15+ Years, Focused Practice

Nearly 15 years devoted exclusively to pharmaceutical regulatory documentation — no generalist consultancy, no learning curve.

One coordinated team

One Coordinated Team

Formulation, analytical, transfer and dossier work delivered by the same specialists — no vendor gaps, no handoffs.

Market-aligned reviews

Market-Aligned Reviews

Documents reviewed against the target market's actual format and review expectations — not a one-size template.

Direct specialist access

Direct Specialist Access

Work directly with the specialists preparing your files. No intermediary layers, no lost-in-translation handoffs.

Our Clients

We are doing very well since last passed 10+ years in the field of pharma regulatory documentation.

Quick Inquiry

Share your requirement and our team will get back to you shortly.

    Have a Product or Registration Project in Mind?

    Share your product name, dosage form, target country and current project stage. We will discuss the support that may be appropriate for your requirements.

    +91 96256 45858 | pharmaactddossiers@gmail.com | Mohali, Punjab, India

    Address

    PharmaActDossiers
    House no. 41, Gurunanak Nagar, baltana,Distt Mohali), Punjab.India
    Phone: + 91 -962-564-5858
    Phone: +91- 701-893-8101
    E-mail: pharmaactddossiers@gmail.com