PRODUCT DEVELOPMENT AND cGMP MANUFACTURING

Whether you have discovered a promising molecule in your laboratory or you have a mature process to be qualified for cGMP so you can access global high end customers, please talk to us. Your challenge will be our mission. Our experts at Pharmatt will help you to advance your product from laboratory to global markets. We will incorporate Quality by Design (QbD) to ensure your processes are optimized and validated in a compliant matter. At Pharmatt, we have the expertise to ensure your processes are in control and capable. We can provide technical support in case of process excursion or quality investigation. We can help you to establish quality system so that your data from validation and stability studies can be accepted by global health authorities for successful approval.  

GLOBAL REGULATORY SERVICES

DMF AND ANDA SUBMISSIONS: 

 

Active Pharmaceutical Ingredients (APIs, Drug Substances):

At Pharmatt we are experienced in filing DMFs, and CEPs in USA and Europe for supplying APIs to regulated markets;

We maintain active DMFs in USA, Europe, Canada, Asia Pacific, and other regulated countries;

CTD/eCTD submissions were successfully sumitted for EU,US, ROW countries.

Finished Formulations (Drug Products):

We file ANDAs in USA, MAs in Europe, Canada, Asia Pacific and Semi-regulated countries.

ANDA Submission: 1) Your product is identical (bioequivalent) to the innovator drug product (the Reference Listed Drug):

  • Dosage form,

  • Strength,

  • Quality,

  • Performance characteristics,

  • Intended use, and

  • Route of administration.

2) Develop an ANDA filing plan which balances risk, speed to approval and cost.

 

3) Produce your ANDA submission, completing all relevant modules. For each module:

  • Determine the required content,

  • Examine the content for suitability,

  • Edit/write/translate as necessary to complete the module.

  • Compile and edit the completed ANDA, making sure it is of sufficient excellence to meet FDA’s rigorous standards, and thus is ready for submission.

 

4) When the document is finalized, we will convert it to Electronic Common Technical Document (eCTD) format, ready to be filed electronically to the FDA.

 

eCTD Deadline Quickly Approaching: FDA requires all DMF submissions to be in electronic common technical document (eCTD) format beginning May 5, 2017.

IND AND NDA SUBMISSIONS:

Pharmatt’s chemistry, manufacturing and controls (CMC) group provides regulatory guidance in setting specifications, method development and validation, and conducts stability studies.

 

In addition, we identify contract manufacturers, arrange contract laboratory services and conduct good manufacturing practice (GMP) audits.

At Pharmatt we work with Innovator Companies to write INDs/NDAs (CMC Section-Module 1, 2 & 3).

 

We have experience of review and compilation of Toxicology, Pharmacology and Clinical Sections (Module 4 & 5).

CTD/eCTD submissions with MRPs & DCP procedures in Europe.

INDs/Clinical Trial Applications:

IND expertise in compilation of CMC, pre-clinical and clinical review including regulatory development strategy.

IND filing experience in US, Europe (France, Hungary, Czech, Netherlands), Australia, New Zealand, Argentina and India

CTA (in Phase I and Phase II and III) filed in various countries in Europe, Canada, US and India.

For INDs filed by clients, we will work with clients to complete IND filing for co-development.

Post approval maintenance – submission of PAS, CBE 30/CBE, Annual Reports to US, Variations to EU.

Electronic Site Registrations, GDUFA obligations such as Site Identifications, Drug listing and SPL support for labeling for US.

Herbal products in Phase II/III clinical trial.

 

Vitamin dossiers supporting to food industry including food facility registration to US.

Pharmatt will act as your Agent and submit the finished dossiers in eCTD format to the FDA.

GLOBAL REGISTRATIONS: 

 

At Pharmatt we have global regulatory experience of 70 countries for Chemistry, Manufacturing and Controls (CMC) submissions.

 

Preparation and review of regulatory submissions, including:

  • Investigational new drug (IND)

  • Clinical trial authorization (CTA)

  • Investigational medicinal product dossier (IMPD)

  • New drug application (NDA)

  • Marketing authorization application (MAA)

  • Abbreviated new drug application (ANDA)

Authoring of annual reports, drug master files, dossier amendments and supplements.

Preparation, publication and submission of electronic common technical documents (eCTD) applications.

Direct interactions and negotiations with U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other national agencies.

Active Pharmaceutical Ingredients (API) and Clinical Trial Material Sourcing and Management.

Project-specific site visits and cGMP audits to evaluate vendor personnel and facility capabilities to execute the program.

Interpretation of scientific results.

Alternative approaches to keep clinical development programs on schedule.

Advice on setting appropriate specifications, assigning product shelf-life and conducting failure investigations.

Customized solutions for small virtual Companies.

Access to pre-clinical toxicologists and pharmacokineticists.

Access to clinical therapeutic area experts

Comprehensive regulatory services.

QUALITY SYSTEM IMPLEMENTATION AND AUDIT READINESS

Our experts at Pharmatt will conduct initial GMP/GLP gap assessment of our customer company & operations, then we will design and customize quality system to fit for customer purpose. We also assist our customers in implementation and training.

Our experts at Pharmatt also conduct periodic reviews of remediation progress for FDA audit readiness, we provide GMP and quality system training as well as assist our customers for inspection deficiency letter remediation and compliance system development.

QUALITY CONTROL, ANALYTICAL AND STABILITY TESTING

At Pharmatt, our experienced scientists will provide analytical support for your product development, method evaluation, method development, method validation, method transfer, forced degradation studies, extractable and leachable studies (HPLC/MS, GC/MS, ICP/MS), compendial testing (USP, EP, JP, BP) as well as API and finished product release testing, GMP stability studies for early phase and commercial products, reference standard qualification, comparator product testing, impurity identification and structure elucidation, management of reference standards, as well as impurity & metabolite standards.

ICH Stability Testing: Pharmatt has access to a variety of storage conditions for test samples to meet drug development requirements in different markets throughout the world. Stability chambers are fully compliant with ICH guidelines, we have walk-in stability chambers for standard storage conditions (25°C/60%RH, 30°C/65%RH, 40°C/75%RH), small chambers (-70°C, -20°C, 25°C/40%RH, 40°C/NMT 25%RH, 30°C/75%RH) for special container requirements and complex products, and ICH compliant photo-stability chamber.

CONSULTING SERVICES