Precise and accurate documentation is an important part of the pharmaceutical industry, from foundation to regulatory compliance, product development, and operational management. Excellence in pharmaceutical documentation is essential for any company striving for success.
High quality documentation serves as the backbone for meeting regulations and obeying rules and laws. At Medwisdom Lifescience, we are experts in providing complete documentation support to ensure compliance and meeting various regulatory requirements.
Contact Us
Regulatory compliance documentation is the foundation of any successful pharmaceutical business. It ensures your product meets every standard required for approval, market access, and ongoing operations.
Accurate documentation reduces stress during audit and inspection by ensuring your product meets regulatory standards
Precise and up-to-date documents mitigate the risk of failure or delays in the product approval process
Complete regulatory compliance guidelines provide a roadmap for companies to improve efficiency in work
Country-specific documentation aligned with regulatory frameworks like FDA, EMA, ASEAN, CIS, and more
We provide end-to-end documentation support across all areas of the pharmaceutical product lifecycle:
Preparation, management, submission, and review of compliant documents — from research and development, clinical documents, dossier preparation, to post-marketing surveillance (Pharmacovigilance) documents. We ensure end-to-end accuracy for the pharmaceutical industry.
Good Manufacturing Practice (GMP) documentation is essential for upholding product integrity. Our services include drafting of BMPs, BMRs, BPRs, preparation of equipment maintenance reports, CAPA documents, and GMP audit-related document preparation.
Simplifying your documentation processes through setting up Electronic Documents Management Systems (EDMS), digitalization of pharmaceutical documents, and using centralized archives for efficient retrieval of documents.
We offer well-structured SOP development services aligned with regulatory requirements, covering manufacturing, quality control, quality assurance, equipment operation, and more — crafted to be effective, user-friendly, and fully compliant.
Preparation of CTD and eCTD, regulatory compliance for pharmaceutical product registration, post-approval change documents, and drafting of Pharmacovigilance Safety Update Reports (PSUR) and Risk Management Plans (RMP).
Managing and preparing all required documentation for post-approval changes, variations, and renewals to ensure continued regulatory compliance and uninterrupted market access throughout the product lifecycle.
We combine deep regulatory expertise with industry-specific knowledge to deliver documentation support that drives results:
We provide pharmaceutical documentation services globally with country-specific regulatory guidelines. Our team ensures regulatory compliance of documents meeting country-specific frameworks like USA, EMA, ASEAN, CIS, and many more.
From preparation of documents for research and development, clinical trial management, to product approval and post-marketing surveillance, we assist clients in each and every step of the product lifecycle, saving your time and efforts.
Connect with us to avoid costly errors and regulatory pitfalls in the product development and approval process. Our professionals with deep industrial knowledge of compliance documentation help avoid errors and mistakes that cause delays.
Find answers to common questions about regulatory documentation and our support services.
Contact UsThe essential documents required for drug approval typically include:
Medwisdom Lifescience assists in preparing all these documents to regulatory authority standards including CDSCO, FDA, and EMA.
CTD (Common Technical Document): A standardized format developed by ICH (International Council for Harmonisation) for organizing and submitting pharmaceutical product registration dossiers. It consists of five modules covering administrative information, summaries, quality, non-clinical, and clinical data. CTD can be submitted in paper format.
eCTD (Electronic Common Technical Document): The electronic version of the CTD, which follows the same module structure but is submitted digitally. eCTD allows for easier review, updates, and lifecycle management of submissions. It is now mandatory for submissions to the FDA, EMA, and increasingly other global regulatory authorities.
Medwisdom Lifescience provides expert preparation and submission support for both CTD and eCTD formats.
Regulatory documents in pharmaceuticals are all the documents required to comply with regulatory authority requirements throughout the product lifecycle. These include:
GMP documentation is a set of records and written procedures that ensure products are consistently produced and controlled according to quality standards. Key GMP documents include:
An Electronic Document Management System (EDMS) is a digital platform used to create, store, manage, track, and retrieve pharmaceutical documents in a controlled and compliant manner. Benefits of EDMS include:
Medwisdom Lifescience assists in setting up and implementing EDMS solutions suited to your organization's regulatory needs.
A Risk Management Plan (RMP) is a detailed document that describes the known and potential risks of a medicinal product and outlines the measures that will be taken to identify, characterize, prevent, or minimize those risks. An RMP typically includes:
RMPs are required by EMA for all new marketing authorization applications and by other regulatory authorities as part of pharmacovigilance obligations. Medwisdom Lifescience provides expert RMP drafting and submission support.
