Services - Regulatory Affairs

PharmaLeaf is a global regulatory and technical specialist that provides end-to-end regulatory and compliance services across lifecycle management from product development (R&D, Pre-clinical, Clinical Trials) to registration and post approval compliance.

In the past 14 years, we have a proven track record of successfully navigating the evolving regulatory environment across a wide range of innovative therapeutics for quality, speedy, cost-effective approvals (biological, clinical, herbal/nutraceutical, device/diagnostics, cosmetics, veterinary, etc.)

Regulatory Strategy Consulting

Our regulatory intelligence professionals have access to relevant regulatory agencies and have the expertise to summarize and assess global regulatory intelligence to ensure submissions are compliant with evolving regional and local requirements, reducing the impact of re-work on budgets and timelines.

Our clients are provided with reliable and accurate global regulatory information to gain competitive advantage and minimize regulatory risks.
PharmaLeaf helps clients with timely and informed decisions by providing companies

  • exclusive regulatory feedback for multi-country filing
  • comparing regulatory pathway for existing and emerging competitive products
  • preparing for scientific consultation, SEC meetings and inspections
  • keeping abreast with new regulatory trends

Dossier Compilation, Submission and Approval

The PharmaLeaf technical and medical writing team is uniquely qualified to help you collate, organize, write, edit, and create an extensive range of medical and scientific regulatory documentation required to support product development & Life Cycle management. Team PharmaLeaf has the expertise and experience to support dossier submissions across the globe in various formats (eCTD, CTD, NeeS, national, ASEAN etc.)


PharmaLeaf provides end to end services on the labelling requirement that includes Art work and Due Diligence of existing labels for regulatory compliance. PharmaLeaf supports in preparation of new labels for Clinical trials, Medical devices, Food & dietary supplements & finished formulations labels, in accordance with the Global & regional requirements.


The effective supervision, compilation and submission of electronic dossiers is a complex process. The submissions team at PharmaLeaf is equipped with comprehensive knowledge of the evolving global Regulatory guidelines and has experience with review and gap analysis of regulatory documents, medical and technical writing, along with the relevant software knowledge in publishing and submissions leading to quality, speedy approvals of regulatory compliant dossiers.

Post Approval Compliance and Lifecycle Management

Post Approval Compliance

The initial approvals secured for market access is invaluable to the Biopharmaceutical Company and its investors. Maintaining post approval regulatory compliances is critical to retain the product in the market with a competitive label claim throughout its life cycle and has value for in and out licensing opportunities.

Incubator Services

In recent years, PharmaLeaf has acquired techno commercial expertise in life cycle management and has facilitated many pharmaceutical organizations to set up local subsidiaries to get regulatory complaint products to the market quicker. We support this process by garnering operating licenses and building cost efficiencies while reducing market access timelines.

Logistics and Supply Chain

Pharmaleaf holds operating licences facilitating market access during the registration and post marketing phases. We support logistics and supply chain management, compliant with GDP (global and national).

Snapshot of the Regulatory and Compliance Services provided by Pharmaleaf:

Regulatory Approvals Variation Filings Post Approval Submissions Regulatory & Technical Writing Quality Assurance / Compliance
Periodic updates on new / draft guidelines
Classification / Filing Strategy
Scientific Consultation - Agency / Experts
SEC Meetings
Analysis and submission of relevant regulatory data to Experts Committees to garner favorable outcomes (eg: Recommendations / Waivers, etc)
Minor / major notifications and amendments
Type I and II variations - process change, site variation, source variation, others
Shelf life extensions
Additional indications and presentations
Packaging / labelling changes
Annual Reports
Acquired dossiers - MAA transfers across geographies
Clinical & CMC reports (CTD)
Conversion of CTD to eCTD and submission to various global agenices
Justifications and rationale
Literature search
Preparation and checking of labels
Due Diligence, Gap Analysis
GXP Audits
Manufacturing change assessment, regulatory impact across markets
Prescribing Information / Package Inserts compliance
Labeling and promotional material due diligence