Regulatory writing services for drugs and medical devices.

Pepgra offers global regulatory and clinical writing services. The team delivers clinical study protocols and findings with precision. Reports are scientifically accurate, culturally sensitive, and meticulously compliant with regulations and statutory bodies.

Drugs and Medical Devices

Pepgra understands how important it is to write in a manner that is understood by statutory reviewers and regulatory bodies such as EMA (EU), FDA (USA), PFB (Canada), PMDA (Canada), TGA (Australia), MCC (South Africa), ASIAN (Hong Kong), GCC, CIS (Russia) and many other regulators. Moreover, delays and additional revisions can have significant cost implications. Our regulatory medical writing services will help you in composing well-written regulatory documents and ensure that your dossier is reviewed, edited and proofread thereby saving you time and money. Pepgra writers work closely with your statisticians, regulatory and data management teams to deliver meticulous documents that are on par with the highest standards.

Regulatory & Clinical research writing experts have the capabilities and skills to prepare regulatory submission documents required to seek approval for drugs (Abbreviated New Drug Application – ANDA), devices and nutraceuticals (for health claims). The regulatory medical writing solutions we offer include regulatory compliance solutions in preparing essential documents for clinical trial submissions such as investigator brochures (IBs), protocols, dossier development including common technical documents (CTDs), eCTD modules, periodic safety update reports (PSURs), development safety update reports (DSURs), annual safety reports (ASRs), clinical study reports (CSRs), documents related to pharmacovigilance like risk management plans (RMPs), periodic safety update reports (PSURs) and other associated documents.

Pepgra Extensive Regulatory Experiences

Our comprehensive solutions for pharmaceutical companies

Full dossier development

• Clinical Overview (eCTD Modules 2.5) plus literature review
• The Common Technical Document (CTD)
• Module 2.3: Quality Overall Summary (QOS)
• Module 2.4/2.6: Non-Clinical Overview (Pharmacology, Pharmacokinetics, Toxicology) and summary
• Module 2.5/2.7: clinical overview and summary
• Module 3, 4, & Module 5
• Regulatory eCTD dossier preparation, publishing and submission
• Clinical expert statements
• IND/NDA, MAA, PMA, 510(k) preparation and submission in US FDA, EMA Europe, Canada, Asia Pacific, Gulf countries and semi-regulated countries
• Briefing documents
• Labeling and core datasheet
• Gap analysis for clinical part of the dossier
• Pharmacovigilance documents: periodic safety update reports

Pepgra CRO team has extensive knowledge of Pharmacokinetics, Pharmacodynamics, and Pharmacogenomics who can facilitate trial life cycles by establishing efficient processes that reduce costs and deliver a rapid return on investment.

For medical device manufacturers

We offer pre-market Conformité European (CE) mark report, clinical data, and post-market studies. Pepgra has extensive experience in preparing following reports for Class I (low risk), IIa, IIb, and III (high risk): For medical devices, we are compliant with Medical Device Academy (MedDev) 2.7/1 Revision 4 guidelines to perform the clinical evaluation.

• Comparative Effectiveness Research (CER) is part of the approval process thereby allowing market access (with CE-mark) for a medical device
• Clinical data: safety and/or performance of information generated from clinical use of a device in question or a similar device for which equivalence has been demonstrated
• Equivalent device report: similar technical, biological and clinical characteristics
• In-depth literature search and appraisal of relevant publications
• Premarket, CE-mark studies, post-market studies and registries

Our Expertise and Experience

Here are the advantages of roping in Pepgra experts:

• Well-versed in working with various stakeholders like clinical operations, data management, biostatistics, medical and safety teams to deliver documents.
• Experience in writing documents for various phases of clinical development including Phase I to Phase IV, PMS and Post-Authorization Safety Studies (PASS).
• Includes medical devices, prescription drugs (with extensive knowledge of pharmacokinetics, pharmacodynamics, and pharmacogenomics), over-the-counter medicines, veterinary medicines, cosmetics, biologics and nutraceuticals.
• Complete understanding of drug development process, including New Chemical Entities (NCEs), generic, biologics and biosimilars.
• Adherence to country-specific guidelines and norms.
• Knowledge of guidelines pertaining to the following: GPP3, International Committee of Medical Journal Editors (ICMJE), Consolidated Standards of Reporting Trials (CONSORT), Strengthening the Reporting of Observational studies in Epidemiology (STROBE), Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) and other applicable regulatory guidelines

Other guidelines include the following: Association of the British Pharmaceutical Industry (ABPI), Standards for Reporting of Diagnostic Accuracy (STRAD), ICH, FDA, and MedDev.

Our Experts (Regulatory Medical Writers):

• Our geographically and professionally broad team of regulatory writers are qualified to the MSC, MD, MBBS, PharmD. or PhD level and possess extensive regulatory knowledge of industry guidelines located in 100+ countries.
• Our geographically and professionally broad team of regulatory writers are qualified to the MSC, MD, MBBS, PharmD. or PhD level and possess extensive regulatory knowledge of industry guidelines located in 100+ countries.
• Our regulatory medical writers have vast experience in writing and editing a wide range of clinical trial documentation involved in the regulatory process.
• Our writers undergo regular training conducted by the AMWA (American Medical Writers Association) and the EMWA (European Medical Writers Association) and other recognized medical writing organization to keep their skills at the vanguard of the medical writing field.
• Our translation team consists of native speakers with many years of experience in translating all documents necessary for the performance of clinical studies.

Therapeutic Areas that we work

• Vast experience in working across multiple therapeutic areas like Biochemistry, Diabetes, Gastrointestinal, Renal/Nephrology, Respiratory, Psychiatry, Rheumatology, Cardiovascular, Toxicology and Oncology

Editing & Formatting:

• Submission-ready documents in terms of technical information, language, format, and template used to prepare the document

Our Quality Control & Assurance:

• All our clinical development services are done in accordance with our SOPs compliant standards. All our regulatory documents undergo thorough scientific, medical, editorial, quality check and assurance to ensure that the clinical documents we produce are scientifically accurate.
• The documents are prepared using sponsored-provided materials SOPs or Pepgra suite of International Conference on Harmonization ICH-compliant templates and style guides. In either case, Pepgra medical writing team ensures that the document we produce is of the highest quality in terms of scientific content, style and formatting.

Delivery:

• Timely delivery of the highest standard of quality
• Culturally sensitive to the locale and competitive price

Our regulatory medical writers hold vast experience in handling a wide range of therapeutic areas and all phases of development that are sound from both a scientific and regulatory perspective.